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MERLIN-TIMI 36: Study design
IV/oral ranolazine Placebo
Patients with non-ST elevation ACStreated with standard medical/interventional therapies
N ~ 5500
Anticipated completion 2006
Primary outcome:CV death, MI, recurrent ischemia
RandomizedDouble-blind
Lüscher T. Eur Heart J Suppl. 2004;6(suppl I):I17-8.MERLIN-TIMI 36 Study Group. www.clinicaltrials.gov.
Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST elevation acute coronary syndrome–Thrombolysis In Myocardial Infarction 36
COURAGE: Study design
Boden WE et al. Am Heart J. 2006.
Aggressive medical therapy Aggressive medical therapy + PCI
CCS Class I–III angina, stable post-MI, or documented asymptomatic myocardial ischemia
N = 2287
5 years
Primary outcome:All-cause mortality, nonfatal MI
Randomized
Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation
COURAGE: Lifestyle modification goals
Smoking Cessation
Total dietary fat <30% of calories
Saturated fat <7% of calories
Dietary cholesterol <200 mg/day
Physical activity ≥30 min moderately intensive exercise 5 times per week
BMI (kg/m2) <25 (if baseline 25.0–27.5)
10% relative weight loss (if baseline BMI >27.5)
Boden WE et al. Am Heart J. 2006.
Lifestyle characteristics Goal
COURAGE: Medical therapy goals
LDL-C (mg/dL) 60–85
HDL-C (mg/dL) ≥40
Triglycerides (mg/dL) <150
BP (mm Hg) <130/85<130/80 if diabetes or renal disease present
A1C (%) <7.0
Boden WE et al. Am Heart J. 2006.
BARI 2D: Study design
Aggressive pharmacologic CV therapy
Aggressive pharmacologic CV therapy +
coronary revascularization
Patients with type 2 diabetes and angina or asymptomatic myocardial ischemiaN = 2322
Primary outcome: All-cause deathSecondary outcome: All-cause death, Q-wave MI, stroke
Double-blind, 2x2 factorial
Bypass Angioplasty Revascularization Investigation 2 Diabetes
Insulin–sensitizer-based antidiabetic therapy
Insulin-based antidiabetic therapy
Sobel BE et al. Circulation. 2003;107:636-42.
5 years
Randomize
Randomize
Vascular endothelial growth factor
Fibroblast growth factor
Cell therapy
Biological revascularization: New frontiers
Kawamoto A et al. Circulation. 2001;103:634-7.Losordo DW and Kawamoto A. Circulation. 2002;106:3002-5.
Control (medium)Control (medium)
Kawamoto A et al. Circulation. 2001;103:634-7.
EPCEPC
106 human cells administered 3 hours after induction of myocardial ischemia in male athymic nude rats
EPC = endothelial progenitor cells
Transplanted EPCs: Reduction in fibrosis
Stem cell therapy for intractable angina:Study design
Saline control 1 x 105/kg
Patients with intractable CCS class III or IV angina not suitable for CABG or PCI N = 24
Cross-over permitted at 6 months(CCS class III or IV, abnormal SPECT, ETT < 6 min)
Losordo DW et al. VBWG US chapter meeting. March 2006; Atlanta, Ga.
5 days GCSF (plus ASA, clopidogrel, statin)/apheresis/CD34+ cell selection
*Sub-therapeutic dose in preclinical studiesGCSF = granulocyte colony-stimulating factor
5 x 104/kg* 5 x 105/kg
Injected into hibernating/ischemic myocardium
Double-blind, placebo-controlled
Summary
• Despite availability of effective medical and interventional modalities, patients with stable CAD continue to experience ischemic events
• In special populations (eg, women) CAD needs to be more aggressively diagnosed and treated
• Ongoing trials may help better define the role of aggressive medical therapy with/without PCI