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Division of Clinical Research & Training

St. John’s Research Institute

Bangalore, India

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• To develop and conduct Clinical Research with specialrelevancetoIndiaandotherdevelopingcountries

• To achieve world class research standards at ‘realistic’costs

• Totransformknowledgetobetterhealththroughadvocacyandpolicychange

Division of ClinicalResearch & Training

Our Mission

Division of Clinical Research & TrainingSt. John’s Research InstituteSt.John’sNationalAcademyofHealthSciences,Bangalore-560034Karnataka;IndiaTel:+91-80-49467081/82/83/84Fax:+91-80-49467090ForEnquiries,PleaseE-mail:info_dcrt@sjri.res.in

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About us

TheDivision of Clinical Research andTraining is a part of St. John’sResearchInstitute,establishedintheyear2000.TheSt.John’sResearchInstitute (SJRI) is one of four institutions of the St John’s NationalAcademy of Health Sciences. The other institutions are St. John’sMedical CollegeHospitalwith1200 beds, St. John’sMedical Collegerankedoneamongthetop ten Medical Colleges inIndiaandSt.John’sCollegeofNursing.

Fromitsinception50yearsago(in1963)St.John’ssetbeforeitanidealofexcellenceinacademictrainingaswellasservicetosociety.

In 2000,St. John’scommitment toexcellence inresearch led tosettingupanInstitutededicatedtoresearchandcapacitydevelopment.

TheResearchInstitutehas8Divisions:

1. Clinical Research and Training

2. Epidemiology and Biostatistics

3. Health and Humanities

4. Infectious Diseases

5. Medical Informatics

6. Mental Health and Neurosciences

7. Molecular Medicine

8. Nutrition

The Division of Clinical Research and Training designs and conductsnational and international clinicaltrials and observational studies incardiovascular disease (CVD). Ourcollaboration includes about 200institutions - the largest networkof academic clinical researchers inIndia. We have recruited more than60,000subjectsindifferentstudiesinjust over a decade.Most of these areinvestigator-initiated studies funded

by peer-reviewed grants while somearesupportedbyIndustry.

Our studies have been published inleadingjournalsincludingtheLancet,JAMA, NEJM, Nature Cardiovascular,American Heart Journal, Circulation,EuropeanHeartJournal,IndianHeartJournal,JAPI,etc.(SeePages)

Tofocusonknowledge translational research and training in health research methods, we recentlyformed the Indian CardiovascularResearchandAdvocacyGroup(ICRAG)in collaboration with McMasterUniversity, Canada and three otherInstitutionsinIndia(RajahMuthaiah,Annamalainagar, Mahatma GandhiInstitute,SevagramandFortisEscortsHospital,Jaipur).WearerecognisedasaCenterofExcellencebytheNationalHeart Lung Blood Institute (NHLBI)NationalInstituteofHealth(NIH,USA)andUnitedHealth tocounterchronicdiseasesindevelopingcountries.

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Our TeamDCRThasadedicatedandhighlyqualifiedTeamfor theconductofClinicalResearch.The team is led by Dr. Prem Pais andDr. Denis Xavier.

Dr. Prem Pais M.D.,Professor of MedicineChief Mentor, Division of Clinical Research & Training

Dr.PremPais,isoneofIndia’seminentclinicalresearchersinpreventivecardiology.HeisonthereviewboardoftheIndianCouncil of Medical Research (ICMR) and a reviewer of theDavidson’s Textbook of InternalMedicine. He is the steeringcommittee member and Principal Investigator of severallarge registries, case control studies and clinical trials thathave identified risk factors and defined the evidence for thetreatment of cardiovascular disease. Dr. Pais is the co-chairoftheNIHCentreofExcellencetocounterchronicdiseasesindevelopingcountries.

Dr. Denis Xavier M.D., M.Sc (Clin Epi)Vice Dean (PG)Professor and Head of Pharmacology, SJMCHead, Division of Clinical Research & Training

HehashelpedunderstandtheriskfactorsforCVD(INTERHEART,INTERSTROKE case control studies), practice patterns andoutcomesinCVD(CREATE,INSPIRE,RELYregistries)andtheeffect of antiplatelet, anticoagulants, antihypertensive, lipidlowering drugs and a Polypill (POISE, VITATOPS, PROFESS,ASPIRE, OASIS, TIPS, TIPS-3, TIPS-K, HOPE-3, ARISTOTLE,RECREATE,AVVEROES).Hewas thePrincipal Investigatorofthe‘CentreofExcellence’awardbytheNHLBI(NIH,USA)andUnited Health under their Global Health Initiative program

Academic Collaborators:

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Dr. Padmini Devi M.D.,Associate Professor of Pharmacology, SJMC

CoInvestigatorforMARSandAMENDprogram.AcorememberoftheHealthResearchMethodologiestrainingteam.Herareasofinterestincludediabetesandcardiovascularresearch.

Dr. Atiya Faruqui, MDAssociate Professor of Pharmacology, SJMC

Co-investigatorinobservationalstudiesincardiovasculardisease-FRIENDS Study (primary care physicians) and SPECTRUM(secondaryandtertiarycarephysicians);VISIONStudy(AcohortstudyinPeri-operativecardiacIschaemia).Sheiscurrentlyinvolvedinareasofhealthpromotion,coordinatingthedevelopmentofawebsite,aswellasworkingwithprimarycarephysicians.

(2009-2014). He conducted knowledge translational studiesand managing comprehensive training programs for about1100healthprofessionalsinhealthresearchmethods.Hewasthe Principal Investigator of the SPREAD trial evaluating theimpact of community health worker based interventions inthe secondary prevention of acute coronary syndromes (14centers, 800 patients) and co-investigator of the PREPAREtrial,aclusterRCTevaluatingtheimpactofcommunityhealthworkersinprimarypreventionamongruralcommunities.HewasalsothePrincipalInvestigatorofINSPIREa10,500patientStrokeRegistryfromallregionsofIndia.

Government Collaborators:

Dr. Mangala Rao, MDAssistant Professor of Pharmacology, SJMC

Co-investigatorofaSystematicReviewofallthecardiovascularstudiesconductedinIndia,involvedinanobservationalstudyinprimarycarephysicians(FRIENDS).SheistheProjectofficerforthemulticentricPOISE2(PeriOpertiveIschemicEvaluation)trial.Sheiscurrentlyinvolvedinlookingatthepracticepatternsforchronicdiseasesamongprimarycarephysicians.

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Dr. Deepak Kamath M.D.,Assistant Professor of Pharmacology, SJMC

Co-InvestigatorfortheTIPS-3polypilltrialandIMPACT-AF.HeisalsothetrialmanagerforAPOLLO,HOPE-3andotherlargetrials.

Godfreeda DenisB.Sc (Microbiology), MSc (Clinical Trials & Regulatory affairs)

Senior Coordinator in the Division of Clinical Research andTraining from 2001. Her interest includes coordination ofmulticentre drug trials, registries and observation studies inCardiovasculardisease.Shealsoheadsthemonitoringgroup.

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Nandini MathurM.Sc (Microbiology)

Senior Study Coordinator from 2004 and has experience incoordinating large multicentre randomized clinical trials,case control studies and registries. She is also the programcoordinatoroftheHealthResearchMethodologies&Trainingunder mentorship program conducted by the NIH-NHLBI-UnitedHealthfundedCentreofExcellenceaswellasofPfizer’sPreferredResearchCentre.

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Our ContributionClinical Research

1. GeneratedevidencefromadevelopingcountryonriskfactorsandpracticepatternsforAcuteMI

• IndianCasecontrolstudyandINTERHEART • CREATERegistry

2. GeneratedevidenceonriskfactorsandtreatmentsforStroke • INTERSTROKE,INSPIRE

3. ContributedtoGlobalRCTsthathaveimpactedclinicalpractice • CREATEStudy–useofLMWH&GIKinAcuteMI • OASIS5&6–useoffondaparinuxinACS • RELY,ARISTOTLE-Novelanticoagulantsinatrialfibrillation

Trials in Health System Research • PRoFESS–largestsecondarystrokepreventionstudy • POISE1&2–largestclinicaltrialsevaluatingtreatmentsinperioperative

ischemia • TIPS-1,2&3–RCTsevaluatinga“Polypill” • PREPARE-Randomizedtrialevaluatingprimarypreventionstrategiesat

thecommunitylevel. • SPREAD -Randomized trial evaluatingpost discharge interventions in

ACSpatients.

Training • Researchmethodologycourseformedicalprofessionals • Trialmanagementcourseforresearchcoordinators • ClinicaltrainingforBiomedicalIndustry

Industry Collaborators:

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Our Capacity for Clinical Research• At about 200 sites across

the country and about 500investigators.

• Team of trained & experiencedcoordinators and researchassistants, about 50 at St. John’sand500acrossthecountry.

• Capacity to coordinate largemulticentreglobalclinicaltrials

• Regulatory Approval - National &International

• Investigational Product –Importation, storage,redistribution&accounting

• A State of the Art Storage facilitywhich is access controlled andtemperaturecontrolledtostore

• The store distributes drugs andmaterials toover500sitesacrossIndia.

• SampleStorage

• A Bio-repository for long termstorage of biological samples. Ithas the capacity to store 80,000samples.

ClinicalTrialSupplies

SampleStorage

ClinicalResearchAssistants

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Data Management

• DevelopCaseReportForms

• Setupdatabase

• Handle data from over 100sites (receive forms, enterdata, generatequeries, resolvequeries,rollingdatabaselock)

Bio Statistics

• Consultant for - study design and methodologies, Questionnairepreparationand databasedevelopment

• Carries out - Sample size calculation, Randomization schedule preparation, Data quality checks, Statistical analysis and result interpretation and contribute tomanuscriptpreparation.

BioStatiscticsTeam

DataManagementTeam

DataServer

Twodedicatedserversthatcansupportdatabases. It has facilitated remotedata capture for global multicentreclinical trial. Over 15 Years trained150 sites across the country in datacapture, supported central databaseswith resolution of queries in casereportforms.

We have licensed Promasys, aversatile database managementsystem.This uses the study life cycleconcept, creates data capture forms,buildeditchecksandoverallenhancesefficiencyindatamanagement.

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Research Training at DCRTWeconductvarioustrainingprogramsinHealthResearchMethodsforphysiciansand Research management for research support staff. We are a NationalInstitutesofHealth(NIH,USA)CentreofExcellence(CoE)toconducttraininginhealthresearchmethods.WearealsorecognizedasaPreferredResearchCentre(PRC)byPfizer,toconducttraininginclinicalresearch.

Todate,wehavetrained1100participantsfrom60institutionsspreadacross33citiesin7countries.

1. Two-year Research trainingthrough mentorship (2009,2011,2011-2013)

2. Two week course in HealthResearch Methodology (2009,2011)

3. Two week course in AdvancedHealth Research Methodology(2010,2012)

4. Six months in UndergraduateResearch Mentorship (2009,2010,2011,2012,2013)

5. Three days course in ClinicalResearch Management (2011,2013)

6. Three days course in ResearchMethodology & Good ClinicalPractice for physicians (2010,2012)

7. One week course in HealthResearch Methodology &EvidenceBasedMedicine(2013,2014,2015)

8. One day Nurses ResearchWorkshop in collaborationwithGlobalResearchNursesnetwork(2013)

9. Three day course on DataManagement and Biostatisticsforhealthprofessionals(2014).

10. Two days workshop for setting

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Ongoing Studies

up Non-Communicable diseasesPrevention and Training units(NPTU’s)(2014)

11. Three days training programon clinical diabetes and HealthResearch Methodology (2014,2015)

12. OnedayprogramonAccreditationfor Clinical Research-Awarenessandexpectation(2015)

13. OneweekseminaronWorldHeartFederationemergingleaderthinktankseminar(2016)

Most of our training is conducted incollaboration with PHRI, McMasterUniversity, Canada. We initiated aundergraduate medical student’smentorship program at MGIMS,

1. HOPE-3 - A trial to evaluatethe safety and efficacy ofrosuvastatin and cadesartan/hydrochlorothiazide and theircombinations in middle agedpeople, who are at intermediaterisk for vascular events (Global–11,000/India–2000)

2. TIPS-3-Aclinicaltrialofpolypillin primary prevention setting toreduce cardiovascular outcomes(Global–5000/India–2000)

3. MACE Registry- A nation wideobservational study in AcuteCoronary Syndrome (ACS)(India-10,000+)

4. AMEND PHASE II- An ongoingprogram (research, patientmanagement strategies) toprevent&manageCVDs in India(India-10,000)

5. STABILITY-RCT to evaluate theeffectsofchronictreatmentwithdarapladib in high-risk patients

Sevagram and at St. John’s whichcompleted6batches(2009-2015).

We are a pre vetted site for theFogarty Fellowship program. Healthprofessionals can apply to conductresearch at St. John’s with financialandtechnicalsupportfromtheFogartycenterbasedintheUSA.

The PRC activities at St. John’s areoverseen by a Steering Committeewhich includes members from St.John’s and Pfizer India Ltd. Thetraining activities include two short-term courses for Clinicians in HealthResearch Methods and Good ClinicalPractice (GCP), and Site ResearchCoordinators in Clinical ResearchManagementandGCP.

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with chronic CHD(Global –15,828/India-398)

6. IMPACT-Aclusteredrandomizedcontrolledtrialtoimprovestrokeinpatientswithatrialfibrillationby improving treatment withanticoagulants (Global –1800/India-494)

7. HF-CHW- Health workers toenhance adherence to treatmentandselfcareamongheartfailurepatients(India-30)

8. ODYSSEY- A phase III trial toevaluate the lipid loweringefficacyofamonoclonalantibodythat blocks PCSKA receptors(Global-18,000/India-521)

9. MANAGE- Randomized clinicaltrial of Dabigatran in perioperative myocardial infraction(Global-1750/India-250)

10. CANTOS- RCT of subcutaneouscanakinumabinthepost-MIwithelevated hsCRP (Global- 17,200/India-1,200)

11. PROGRESS- Policy and peeRmentor intervention proGrams

1. MACE Registry - A nation wideobservational study in AcuteCoronarySyndrome(ACS)(India–10,000+)

2. VISION -A large cohort study toevaluatemajorvasculareventsinpatients undergoing non-cardiacsurgery (Global- 40,000/India –4000,JAMA2012)

3. AMEND - An ongoing program(research, patient management

oncardiovasculardiseaseatworkSites in 3 South Asian countries(India-3,000)

12. AUGUSTUS- Apixaban versusVitaminKAntagonist inPatientswith Atrial Fibrillation andAcute Coronary Syndrome and/or Percutaneous CoronaryIntervention (Global 4,600/Inida-400)

13. TREAT- Compare ticagrelor withclopidogrel in STEMI patientstreated with fibrinolytic therapywithin 24 hours (Global- 4,000/India-600)

14. BPHomeMonitoring-Perceptionof patients and healthcareproviders on patients’ selfmanagement of blood pressure:A pilot mixed methods study(Global-150/India-25)

15. PANACEA-HF- Piloting a qualityimprovement intervention foroptimal medical managementof patients with chronic Heartfailure(India-230)

Completed Studiesstrategies) to prevent &manageCVDsinIndia(India–10,000)

4. INSPIRE-Anobservationalstudyto determine etiologies, clinicalpracticepatternsandoutcomesofstrokesinIndia(India–10,500)

5. SPREAD - A randomized trialcomparing post dischargeinterventions by CHWs tostandard care in ACS patients(India–800)

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6. ICMR - A case control study tostudy the risk factors forAMI inIndians(India–2000)

7. INTERHEART - A case controlstudy of risk factors for AMI inall regionsof theworld (Global–29,972 / India – 3000, Lancet2004/JAMA2006)

8. CREATE – RCT of Reviparin andorGIKVsplaceboinAMI(Global–20,201/India–8060,JAMA2004/AHJ2004)

9. POISE-MetoprololvsplaceboinPeri Operative Ischemia (Global–8351/India–777,Lancet2008)

10. CURRENT - RCT of standardvs high dose of clopidogrelin unstable angina or non-STsegment elevation (Global –25000/India–2250)

11. PrePare - A cluster randomizedtrial to evaluate primaryprevention strategies at thecommunity level to promotetreatment adherence to preventcardiovascular disease (India –27,000)

12. CREATE ACS Registry - Toexamine the treatment patternsand outcome of ACS patients inIndia(GlobalandIndia–20,468,Lancet2008

13. POISE-MetoprololvsplaceboinPeriOperativeIschemia(Global–8351/India–777,Lancet2008)

14. PRoFESS - RCT of Dipyridamole,Clopidogrel & Telmisartan inischemicstroke(Global–20,333/India–1,620,NEJM2008)

15. TIMACS - RCT of timing ofIntervention in ACS (Global –3031/India–31,AHA2008)

16. OASIS 5 - RCT of fondaparinuxVs enoxaparin in unstable/non-ST-segment elevation MI(Global-20,078 /India – 522,NEJM2006)

17. OASIS6-RCTofFondaparinuxVsplaceboinSTEMI(Global-12,092/India–1444,JAMA2007)

18. RELY - RCT of dabigatrin Vswarfarin in atrial fibrillation(Global – 18113 /India – 578,NEJM,Lancet)

19. VITATOPS-RCTofmulti-vitaminsvs placebo in secondary strokeprevention(Global–8167/India–1421,IntJofStroke,2007)

20. AVVEROES - RCT of apixaban VsASA to prevent stroke in atrialfibrillation patients who hadfailedorareunsuitableforVit-Kantagonist(Global–5000/India–203,NEJM2011)

21. ARISTOTLE - RCT to evaluateapixaban in preventing strokeand systemic embolism in atrialfibrillation (Global – 18,000/India–601,NEJM2011)

22. RECREATE - RCT of Intensiveinsulin therapy targetingnormoglycemia in acute MI(Global – 287/India – 273, DiabCare2011)

23. RIVAL - RCT of radial versusfemoral PCI Access in UnstableAngina or Myocardial Infarction(Global–7000/India–340,JAMA2012)

24. INTERSTROKE - A casecontrol study to determine theimportance of conventionaland emerging risk factors for

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stroke (Global – 24,000/India –5000,Lancet2011)

25. APOLLO-Arandomizedcontrolledtrialofaliskireninthepreventionofmajorcardiovasculareventsinelderlypeople (Global –11,000/India–1600)

26. APPRAISE 2 - A trial to evaluateapixaban in patientswith recentACS (Global – 10,000/India –1078)

27. RELY-AF Registry – Anobservationalstudytodeterminepredisposing conditions &regional variations in atrialfibrillation/ flutter (Global–15,000/India–2500)

28. ASPIRE-Arandomizedcontrolledtrial of low-dose aspirin afterinitial anticoagulation topreventthe recurrence of venousthromboembolism (Global –2000/India–400)

29. FRIENDS-AProspectiveStudyofPractice Patterns and Outcomesin Chronic Disease in an Urban

Family Practice Setting (India –2000)

30. SPECTRUM - Situational analysisof the practice patterns incardiovascular disease in allregionsofIndia(India–1300)

31. OASIS-8/ FUTURA - RCT toevaluate standard Vs low doseadjunctive i.v. UFH in patientsundergoingPCI(Global–2000/India–500,JAMA2010)

32. MARS - A five arm RCT ofamlodipine + metoprolol XL& amlodipine as individualcomponents in Indians (India –400,BloodPressure2011)

33. POLYCAP - A 9 arm RCT of aPOLYCAP Vs its components insubjects with at least one CVriskfactors(India–2053,Lancet2009)

34. TIPS-K - RCT of low strengthpolycap & of low strength K+supplementation in patientswith stable CVD/ ischemic heartdisease(India–500)

Abbrevations:

ACS:AcuteCoronarySyndrome,CHW:CommunityHealthWorker,CVD:CardioVascularDisease, RCT: Randomized Controlled Trial, AMI: Acute Myocardial Infarction, MI:Myocardial Infarction, STEMI: ST-Elevation MI, UFH: Unfractionated Heparin, ASA:Aspirin,PCI:PercutaneousLMWH:LowMolecularWeightHeparinGIK:GlucoseInsulinPotassiumIntervention,K+:Pottassium)

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1. PaisP,Pogue J, JayprakashS,Yusuf S, et al;Risk factors foracutemyocardial infarctionin Indians:case-controlstudy.Lancet1996.PMID:8709733.

2. Yusuf, S., Hawken, S., Ôunpuu, S., Dans, T.,Avezum, A., Lanas, F., Pais P et al. Effect ofpotentiallymodifiableriskfactorsassociatedwithmyocardial infarzction in52countries(theINTERHEARTstudy):case-controlstudy,Lancet2004-937-952.PMID:15364185

3. Yusuf S, Mehta SR, Pais P, Xavier D, et al;CREATE-ECLA investigators and steeringcommittee. Challenges in the conduct oflarge simple trials of important genericquestions in resource-poor settings: theCREATEandECLAtrialprogramevaluatingGIK (glucose, insulin and potassium) andlow-molecular-weight heparin in acutemyocardial infarction. AmHeart J. 2004Dec;148(6):106878.PMID:15632895.

4. YusufS,MehtaSR,XavierD,PaisP,ZhuJ,LiuL, et al; CREATE Trial Group Investigators.Effectsofreviparin,alow-molecular-weightheparin, on mortality, reinfarction, andstrokes in patients with acute myocardialinfarction presenting with ST-segmentelevation.JAMA.2005Jan26;293(4):427-35.PMID:15671427.

5. Mehta SR, Yusuf S, Díaz R, Zhu J, Pais P,Xavier D, et al; CREATE-ECLA Trial GroupInvestigators. Effect of glucose-insulin-potassiuminfusiononmortality inpatientswithacuteST-segmentelevationmyocardialinfarction: the CREATE-ECLA randomizedcontrolledtrial.JAMA.2005PMID:15671428.

6. Yusuf S, Hawken S, Ounpuu S, et al;INTERHEART Study Investigators. Obesityand the risk of myocardial infarction in27,000 participants from 52 countries: acase-control study. Lancet. 2005 PMID:16271645.

7. KarthikeyanG,XavierD,PaisP.Perspectiveson the management of coronary arterydisease in India. Heart. 2007 PMID:17933988.

8. Díaz R, Goyal A, Xavier D, Pais P, Yusuf S,et al; Glucose-insulin potassium therapyin patients with ST-segment elevationmyocardial infarction. JAMA. 2007 PMID:18042917.

9. HankeyGJ,AlgraA,XavierD,etal;VITATOPS,the VITAmins TO prevent stroke trial:

Selected Publicationsrationale anddesignof randomised trial ofB-vitamin therapy in patients with recenttransient ischaemic attack or stroke Int JStroke.2007PMID:18705976.

10. Cook D, Moore-Cox A, Xavier D, et al;Randomizedtrialsinvulnerablepopulations.ClinTrials.2008;PMID:18283082.

11. OldgrenJ,WallentinL,AfzalR,PaisP,XavierD,Yusuf S;OASIS-6 Investigators.Effectsoffondaparinux in patients with ST-segmentelevation acute myocardial infarction notreceivingreperfusiontreatment.EurHeartJ.2008PMID:18084015.

12. Xavier D, Devereaux PJ, Pais P, YusufS. Polypharmacotherapy for primarypreventionofcardiovasculardisease.IndianHeartJ.2008PMID:19359761.

13. Xavier D, Pais P, P J Devereaux, ChangchunXie,DPrabhakaran,KSrinathReddy,RajeevGupta, Prashant Joshi, Prafulla Kerkar, SThanikachalam, K K Haridas, T M Jaison,Sudhir Naik, A K Maity, Salim Yusuf et al;CREATE registry investigators. TreatmentandoutcomesofacutecoronarysyndromesinIndia(CREATE):aprospectiveanalysisofregistrydata.Lancet.2008PMID:18440425.

14. DevereauxPJ,YangH,YusufS,XavierD,PaisP,etal.Effectsofextended-releasemetoprololsuccinate in patients undergoing non-cardiacsurgery(POISEtrial):arandomisedcontrolled trial. Lancet. 2008 May PMID:18479744.

15. Sacco RL, Diener HC, Yusuf S, Pais P et al;PRoFESSStudyGroup.Aspirinandextended-releasedipyridamoleversusclopidogrel forrecurrentstroke.NEnglJMed.2008PMID:18753638.

16. YusufS,Diener,PaisP,etal;PRoFESSStudyGroup. Telmisartan to prevent recurrentstroke and cardiovascular events.N Engl JMed. 2008 Sep 18;359(12):1225-37. Epub2008 Aug 27.PMID: 18753639;CentralPMCID:PMC2714258.

17. DienerHC,SaccoRL,YusufS,PaisPetal;Effectsofaspirinplusextended-releasedipyridamoleversus clopidogrel and telmisartan ondisabilityandcognitivefunctionafterrecurrentstrokeinpatientswithischaemicstrokeinthePrevention Regimen for Effectively AvoidingSecond Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study.LancetNeurol.2008PMID:18757238.

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18. XavierD, Pais P, Sigamani A, Pogue J, AfzalR, Yusuf S; Indian Polycap Study (TIPS)Investigators.Theneed to test the theoriesbehind the Polypill: rationale behindthe Indian Polycap Study. Nat Clin PractCardiovascMed.2009PMID:19104516.

19. GoyalA,MehtaSR,XavierD,PaisP,YusufS,etal;Glucoselevelscomparedwithdiabeteshistory in the risk assessment of patientswithacutemyocardial infarction.AmHeartJ.2009PMID:19332208.

20. Joshi P, Islam S, Pais P, Reddy S, DorairajP, Kazmi K, Pandey MR, Haque S, MendisS, Rangarajan S, Yusuf S. Risk factorsfor early myocardial infarction in SouthAsians compared with individuals in othercountries.JAMA2009.PMID:17227980.

21. YusufS,PaisP,XavierD,SigamaniA,MohanV, Gupta R, Thomas N. Effects of a polypill(Polycap) on risk factors in middle-agedindividuals without cardiovascular disease(TIPS):aphaseII,double-blind,randomisedtrial.Lancet.2009PMID:19339045.

22. ConnollySJ,EzekowitzMD,YusufS,XavierD,;RE-LYSteeringCommitteeandInvestigators.Dabigatranversuswarfarininpatientswithatrialfibrillation.NEnglJMed.2009PMID:19717844.

23. Goyal A, Mehta SR, Díaz R, Xavier D,Pais P, Yusuf S, et al; Differential clinicaloutcomes associated with hypoglycemiaand hyperglycemia in acute myocardialinfarction. Circulation. 2009 PMID:19948980.

24. PhilippeGabrielStege,SanjitS.Jolly,ShamirR.Mehta,RizwanAfzal,DenisXavier,Hans-JurgenRupprecht, Jose L. Lopez-Sendon, Andrzejbudaj, Rafael Campbell joyner, Janice Pogue,Salim Yusuf; Low-Dose vs Standard-DoseUnfractionatedHeparinforThePercutaneousCoronaryPercutaneousCoronaryInterventionin Acute Coronary Syndromes TreatedWith Fondaparinux: The FUTURA/OASIS-8RandomizedTrial.JAMA2010.

25. O’DonnellM,XavierD,PiasP,YusufSetal;Rationale and design of INTERSTROKE: aglobal case-control studyof risk factors forstroke. Neuroepidemiology. 2010; PMID:20389123.

26. O’DonnellMJ,XavierD,LiuL,YusufSetal;INTERSTROKEinvestigators.Riskfactorsforischaemic and intracerebral haemorrhagicstroke in 22 countries (the INTERSTROKEstudy): a case-control study. Lancet. 2010PMID:20561675.

27. DienerHC,ConnollySJ,XavierD,YusufS;fortheRE-LYstudygroup.Dabigatrancomparedwith warfarin in patients with atrialfibrillationandprevioustransientischaemicattackorstroke:asubgroupanalysisoftheRE-LY trial. Lancet Neurol. 2010, PMID:21059484.

28. Eva Lonn, Jackie Bosch Prem P, Xavier D,Yusuf S ; The polypill in the Prevention ofCardiovascular Diseases: Key Concepts,Current Status, Challenges, and FutureDirections.Circulation2010.

29. Gupta R, Guptha S, Joshi R, XavierD; Translating evidence into policyfor cardiovascular disease control inIndia. Health Res Policy Syst. 2011.PMID:21306620.

30. DevereauxP.J.XavierD,SigamaniA,YusufS,etal;CharacteristicsandShort-TermPrognosisof Perioperative Myocardial Infarction inPatientsUndergoingNoncardiac Surgery: acohort study. Ann Intern Med. 2011.PMID:21502650.

31. John H Alexander, Renato D Lopes, StefanJames, Prem Pais, et al; Apixaban withAntiplatelet therapy after acute coronarysyndrome,NEJM2011.PMID:21780946

32. Kavsak,P.a,Walsh,M.,Srinathan,S.,SigamaniA, Xavier D et al. High sensitivity troponinT concentrations in patients undergoingnoncardiac surgery: A prospective cohortstudy. Clinical biochemistry, 2011 May 24.PMID:21640092

33. Christopher B. Granger, John H. Alexander,John J.V. Prem Pais, et al; Apixaban versusWarfarin inPatientswithAtrialFibrillationNEJMAugust,2011.PMID:21870978

34. Devereaux PJ, Chan MT, Sigamani A, YusufS et al; Association between postoperativetroponinlevelsand30-daymortalityamongpatients undergoing noncardiac surgery.JAMA.June2012PMID:22706835

35. Yusuf S, Pais P, Sigamani A, Xavier D, AfzalR, Gao P, TeoKK et al; Comparison of RiskFactorReductionandTolerabilityof aFull-DosePolypill(WithPotassium)VersusLow-Dose Polypill (Polycap) in Individuals atHighRiskofCardiovascularDiseases:TIPS-2 Circ Cardiovasc Qual Outcomes Jul 2012PMID:2278706

36. HankeyGJ,EikelboomJW,YiQ,LeesKR,ChenC, Xavier D, Navarro JC. TreatmentWith BVitaminsandIncidenceofCancerinPatientsWithPreviousStrokeorTransientIschemicAttack:Stroke.2012Apr3.

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37. Denis Xavier, Alben Sigamani, Deepak Y.Kamath,PremPais.PolypillIsanImportantStrategyforthePreventionofCardiovascularDisease Risk. Journal of Clinical andPreventiveCardiologyApril2012,No.2

38. Timothy A. Brighton, John W. Eikelboom,KristyMann,RebeccaMister,WendyHague,DenisXavier,RafaelDiaz,AdrienneKirby,JohnSimesetal;Low-DoseAspirinforPreventingRecurrentVenousThromboembolism,NEJM2012.

39. Fathima FN, Joshi R, Agrawal T, Hegde S,Xavier D, Misquith D, Chidambaram N,Kalantri SP, ChowC, IslamS,DevereauxPJ,GuptaR,PaisP,YusufS.RationaleanddesignofthePrimarypREventionstrategiesatthecommunity level to Promote Adherenceof treatments to pREvent cardiovasculardiseases.AmHeartJ.2013.

40. Devi P, Xavier D, Sigamani A, Pandey S,Thomas T, Murthy S, Sharma K, BoscoB, Mehta K, Joshi S, Gupta R, Singh G,Hiremath J, Ds C, Nambiar A, Pais P. Effectof fixed dose combinations of metoprololand amlodipine in essential hypertension:MARS--arandomizedcontrolledtrial.BloodPressure2011Suppl2:5-12.Epub2011Oct13.PubMed:21992003.

41. Lars Wallentin, Renato D. Lopes, MichaelHanna, LainThomas,AnneHellkamp, SunilNepal, Denis Xavier. Efficacy and Safetyof Apixaban Compared With Warfarin atDifferent Levels of Predicted InternationalNormalized Ratio Control for StrokePrevention inAtrialFibrillationCirculation.2013;127:2166-2176

42. David A. Garcia, Lars Wallentin, Renato D.Lopes, Laine Thomas, John H. Alexander,ElaineM.Hylek,PatrickCommerford,DenisXavier, Dragos Vinereanu, Hongqiu Yang,andChristopherB.Granger et al;Apixabanversus warfarin in patients with atrialfibrillationaccording topriorwarfarinuse:AmericanHeartJournal,Sept.2013

43. HankeyGJ.FordAH,YiQ,EikelboomJW,LeesKR,ChenC,XavierD,NavarroJC,RanawakaUK, UddinW, Ricci S, Gommans J, SchmidtR, Almeida OP, Van Bockxmeer FM. Effectof B-Vitamins and Lowering Homocysteineon Cognitive Impairment in Patients withPrevious Stroke or Transient IschemicAttack:APrespecifiedSecondaryAnalysisofARandomized,PlaceboControlledTrialandMeta-Analysis.Stroke.2013

44. Botto F, Alonso-Coello P, Chan MT, Villar

JC, Xavier D, Srinathan S, Guyatt G,Cruz P,Graham M, Wang CY, Berwanger O, PearseRM, Biccard BM, Abraham V, Malaga G,Hillis GS, Rodseth RN, Cook D, P, NageleP, Raina P, Yusuf S, Devereaux PJ, VISION,Anesthesiology.2014,Mar;PMID:24534856.

45. P.J. Devereaux, M. Mrkobrada, D.I.Sessler, A. Sigamani, D. Xavier, S. Pettit,S. Chrolavicius, and S. Yusuf et al, for thePOISE-2 Investigators. Aspirin in PatientsUndergoing Noncardiac Surgery. The NewEnglandJournalofMedicine,31March2014.PMID:24679062.

46. P.J. Devereaux, D.I. Sessler, K. Leslie,A. Sigamani, D. Xavier, S. Pettit, S.Chrolavicius, and S. Yusuf et al, for thePOISE-2Investigators.ClonidineinPatientsUndergoing Noncardiac Surgery. The NewEngland Journal of Medicine, March 31st2014.PMID:24679061

47. Deepak Y Kamath, Denis Xavier, AlbenSigamani, Prem Pais: High sensitivityC-reactiveproteinhsCRP)&cardiovasculardisease:AnIndianperspective.IndianJMedRes142,September2015,pp261-268

48. Christopher B Granger, Renato D Lopes,MichaelHanna,JackAnsell,ElaineMHylek,John H Alexander, Laine Thomas, JunyuanWang,MCeciliaBahit,FreekVerheugt, JackLawrence Denis Xavier, Lars Wallentin:Clinical events after transitioning fromapixabanversuswarfarinTowarfarinattheendoftheApixabanforReductioninStrokeandOtherThromboembolicEventsinAtrialFibrillation (ARISTOTLE) trial: AmericanHeart Journal January 2015 Volume 169,Issue1,Pages25–30

49. Mangala Rao, Denis Xavier, Padmini Devi,AlbenSigamani,AtiyaFaruqui,RajeevGupta,PrafullaKerkar,RajendraKumarJain,RajnishJoshi, N Chidambaram, Daya Sagar Rao, SThanikachalam,SS Iyengar,KironVerghese,VMohan,PremPais:Prevalence,treatmentsandoutcomesofcoronaryarterydiseaseinIndians: A systematic review. Indian heartjournal,August2015,vl67,pp302-310

50. EvaLonn,JackieBosch,JanicePogue,AlvaroAvezum,IrinaChazova,AntonioDans,RafaelDiaz,GeorgeJFodor,ClaesHeld,PetrJansky,MatyasKeltai,KatalinKeltai,KamleshKuntiJae-HyungKim,LawrenceLeiter,BasilLewis,Lisheng Liu, Patricio Lopez-Jaramillo, PremPais,AlexandrParkhomenko,RonJGPeters,Leopoldo S Piegas, Christopher M Reid,Kares, Sliwa, William D Toff, John Varigos,

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Denis Xavier, Khalid Yusoff, Jun Zhu, GillesDagenais,SalimYusuf,NovelApproachesinPrimaryCardiovascularDiseasePrevention:The HOPE-3 Trial Rationale, Design andParticipants’ Baseline Characteristics:Canadian Journal of Cardiology, 2015,32(3):311-8

51. Prem Pais, Deepak Y Kamath, AlbenSigamani, Denis Xavier. Prevention ofCardiovascularDisease:ThePolypillConcept;Pathophysiology and Pharmacotherapy ofCardiovascularDisease,2015,pp613-632.

52. Prem Pais, Deepak Y. Kamath, AlbenSigamani, Denis Xavier: Prevention ofCardiovascularDisease:ThePolypillConcept;Pathophysiology and Pharmacotherapy ofCardiovascularDisease,2015,pp613-632.

53. Xavier D, Gupta R, Sigamani A, KamathDY,Devereaux PJ, George N, Joshi R, Pogue J,Pais P, Yusuf S. Community healthworkerbased intervention for adherence to drugsand lifestyle change after Acute CoronarySyndrome: a pilot randomized controlledtrial. Lancet Diabetes and EndocrinologyMarch2016.

54. Gerald S. Bloomfield, Denis Xavier,DeshiréeBelis,DewanAlam,PatriciaDavis,Prabhakaran Dorairaj, Hassen Ghannem,RobertH.Gilman,DeepakKamath,SylvesterKimaiyo, Naomi Levitt, Homero Martinez,GabrielaMejicano, J. JaimeMiranda,TraceyPerez Koehlmoos, Cristina Rabadán-Diehl,Manuel Ramirez-Zea, Adolfo Rubinstein,Katherine A. Sacksteder, Krisela Steyn,Nikhil Tandon, Rajesh Vedanthan, TracyWolbach, Yangfeng Wu, Lijing L. Yan.Training and Capacity Building in LMICfor Research in Heart and Lung DiseasesThe NHLBI- UnitedHealth Global HealthCenters of Excellence Program, GLOBALHEART,VOL.11,NO.1,2016March.

55. Vilma E Irazola, Laura Gutierrez, GeraldBloomfield, Rodrigo M Carrillo-Larco,Prabhakaran Dorairaj, Thomas Gaziano,Naomi S Levitt, J Jaime Miranda, AntonioBernabe Ortiz, Krisela Steyn, YangfengWu,Denis Xavier, Lijing L Yan, Jiang He, AdolfoRubinstein.Hypertension prevalence,awareness,treatmentandcontrolinselectedLMICcommunities:resultsfromtheNHLBI/UHG network of Centres of Excellence for

chronic diseases,Global Heart, Volume 11,March2016.

56. Yusuf S, Bosch J, Dagenais G, Zhu J, XavierD,LiuL,PaisP,López-JaramilloP,LeiterLA,DansA,AvezumA,PiegasLS,ParkhomenkoA,KeltaiK,KeltaiM,SliwaK,PetersRJ,HeldC,ChazovaI,YusoffK,LewisBS,JanskyP,KhuntiK, Toff WD, Reid CM, Varigos J, Sanchez-Vallejo G,McKelvie R, Pogue J, JungH, GaoP, Diaz R, Lonn E; HOPE-3 Investigators.Cholesterol Lowering in Intermediate-RiskPersonswithoutCardiovascular Disease.NEnglJMed.2016Apr2

57. Yusuf S, Lonn E, Pais P, Bosch J, López-Jaramillo P, Zhu J, Xavier D, Avezum A,Leiter LA,Piegas LS, ParkhomenkoA,KeltaiM, Keltai K, Sliwa K, Chazova I, Peters RJ,HeldC,YusoffK,LewisBS, JanskyP,KhuntiK, Toff WD, Reid CM, Varigos J, Accini JL,McKelvie R, Pogue J, Jung H, Liu L, Diaz R,Dans A, Dagenais G; HOPE-3 Investigators.Blood-PressureandCholesterolLoweringinPersons without Cardiovascular Disease.NEnglJMed.2016Apr2

58. Krishna Kumar Sharma, Rajeev Gupta,MukulMathur,VishnuNatani,SaileshLodha,Sanjeeb Roy, Denis Xavier. Non-physicianhealthworkers for improvingadherence tomedications and healthy lifestyle followingacutecoronarysyndrome:24-monthfollow-upstudy.IndianHeartJournal,2016.

59. MeenaPRao,AndreaOCiobanu,RenatoDLopes, Kathleen A Fox, Ying Xian, Sean DPokorney, Hussein R Al-Khalidi, Jei Jiang,Deepak Y Kamath, Otavio Berwanger,Denis Xavier, CeciliaMBahit, Carlos Tajer,Dragos Vinereanu, Yong Huo, ChristopherBGranger;AclusteredrandomizedtrialtoIMProvetreatmentwithAntiCoagulanTsinpatients with Atrial Fibrillation (IMPACT-AF): design and rationale.AmericanHeartJournal,2016.

60. Denis Xavier, Rajeev Gupta, DeepakKamath, Alben Sigamani, P J Devereaux,Nisha George, Rajnish Joshi, Janice Pogue,PremPais,SalimYusuf::Communityhealthworker-based intervention for adherenceto drugs and lifestyle change after acutecoronary syndrome:a multicentre, open,randomised controlled trial, The SPREADTrial,LancetDiabetesEndocrinol,Feb2016.

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