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Ongoing Trials in Managing Myocardial Ischemia

Ongoing Trials in Managing Myocardial Ischemia. MERLIN-TIMI 36: Study design. M etabolic E fficiency with R anolazine for L ess I schemia in N on-ST elevation acute coronary syndrome – T hrombolysis I n M yocardial I nfarction 36.

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Ongoing Trials in Managing Myocardial Ischemia

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  1. Ongoing Trials in Managing Myocardial Ischemia

  2. MERLIN-TIMI 36: Study design Metabolic Efficiency with Ranolazine for Less Ischemia in Non-ST elevation acute coronary syndrome–Thrombolysis In Myocardial Infarction 36 Patients with non-ST elevation ACStreated with standard medical/interventional therapiesN ~ 5500 RandomizedDouble-blind IV/oral ranolazine Placebo Anticipated completion 2006 Primary outcome:CV death, MI, recurrent ischemia Lüscher T.Eur Heart J Suppl. 2004;6(suppl I):I17-8. MERLIN-TIMI 36 Study Group. www.clinicaltrials.gov.

  3. COURAGE: Study design CCS Class I–III angina, stable post-MI, or documented asymptomatic myocardial ischemiaN = 2287 Aggressive medical therapy Randomized Aggressive medical therapy + PCI 5 years Primary outcome:All-cause mortality, nonfatal MI Clinical Outcomes Utilizing Revascularization and Aggressive druGEvaluation Boden WE et al. Am Heart J. 2006.

  4. COURAGE: Lifestyle modification goals Lifestyle characteristics Goal Boden WE et al. Am Heart J. 2006.

  5. COURAGE: Medical therapy goals Boden WE et al. Am Heart J. 2006.

  6. BARI 2D: Study design Bypass Angioplasty Revascularization Investigation 2Diabetes Patients with type 2 diabetes and angina or asymptomatic myocardial ischemiaN = 2322 Aggressive pharmacologic CV therapy Randomize Aggressive pharmacologic CV therapy + coronary revascularization Randomize Insulin-based antidiabetic therapy Insulin–sensitizer-based antidiabetic therapy 5 years Primary outcome: All-cause deathSecondary outcome: All-cause death, Q-wave MI, stroke Double-blind, 2x2 factorial Sobel BE et al. Circulation. 2003;107:636-42.

  7. Biological revascularization: New frontiers Vascular endothelial growth factor Fibroblast growth factor Cell therapy Kawamoto A et al. Circulation. 2001;103:634-7.Losordo DW and Kawamoto A. Circulation. 2002;106:3002-5.

  8. Transplanted EPCs: Reduction in fibrosis Control (medium) EPC 106 human cells administered 3 hours after induction of myocardial ischemia in male athymic nude rats EPC = endothelial progenitor cells Kawamoto A et al. Circulation. 2001;103:634-7.

  9. Stem cell therapy for intractable angina:Study design Patients with intractable CCS class III or IV angina not suitable for CABG or PCI N = 24 5 days GCSF (plus ASA, clopidogrel, statin)/apheresis/CD34+ cell selection Double-blind, placebo-controlled Saline control 5 x 104/kg* 1 x 105/kg 5 x 105/kg Injected into hibernating/ischemic myocardium Cross-over permitted at 6 months(CCS class III or IV, abnormal SPECT, ETT < 6 min) *Sub-therapeutic dose in preclinical studies GCSF = granulocyte colony-stimulating factor Losordo DW et al. VBWG US chapter meeting. March 2006; Atlanta, Ga.

  10. 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

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