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A Review of – Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic

A Review of – Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic. Ted Williams Pharm D Candidate Monday Lab. Study Objective. Determine if Clopidogrel + ASA 81mg decreases risk of CV Events vs. ASA 81mg alone. Null Hypothesis

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A Review of – Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic

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  1. A Review of –Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Ted Williams Pharm D Candidate Monday Lab

  2. Study Objective • Determine if Clopidogrel + ASA 81mg decreases risk of CV Events vs. ASA 81mg alone. • Null Hypothesis • Clopidogrel + ASA 81mg no different than ASA 81mg alone in reducing CV Events • Alternative Hypothesis • Clopidogrel + ASA 81mg is superior to ASA 81mg alone in reducing CV Events

  3. Methods • Study Design • Multicenter, randomized, double-blind, placebo-controlled (n=15,603) • Executed by Cleveland Clinic Cardiovascular Coordination Center • Sponsored by Sanofi-Aventis & Bristol-Myers (Plavix Patent holder) • Safety and Efficacy endpoints • Plavix + ASA 81mg vs. Placebo + ASA 81mg • Methods - Inclusions • >45yrs • Established CVD • Multiple risk factors for CVD • DM • Diabetic Nephropathy • Ankle-Brachial index <0.9 • Carotid Stenosis • Carotid Plaque

  4. Methods - Analysis • Efficacy • Primary end point of MI, Stroke, or Death due to CV event/hemorrhage • Secondary endpoint incidence of CV events or hospitalization for CAD related events • 20% Relative Risk Reduction detectable based on power • 2 sided log-rank test • Intent to treat • Non-cardiovascular death excluded from Efficacy endpoint • Safety • Pearson chi-square test

  5. Efficacy Findings Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events. (NEJM 2007;354:1706-17)

  6. Subgroup Analysis • No significant efficacy difference in any subgroup Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events. (NEJM 2007;354:1706-17)

  7. Safety Findings • Moderate Bleeding significantly increased Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events. (NEJM 2007;354:1706-17)

  8. Areas for Future Study • Symptomatic vs Asymptomatic Patients? • Platelet abnormalities?

  9. Hypothesis Testing • Null Hypothesis • Clopidogrel + ASA 81mg no different than ASA 81mg alone in reducing CV Events • Failed to Reject • Alternative Hypothesis • Clopidogrel + ASA 81mg is superior to ASA 81mg alone in reducing CV Events • Rejected

  10. Conclusions • Dual ASA and Clopidogrel therapy is not generally indicated to prevent CV events • Moderate Bleeding is the area of risk • Future research should be conducted to determine potential benefits in patients with establish CV disease

  11. References • Bhatt, B., Fox, D., Hacke, W., et al, (2007) Clopidogrel and Aspirin versus Aspirin Alone for the Prevention of Atherothrombotic Events. NEJM 2007;354:1706-17. Retrieved from http://content.nejm.org/cgi/content/full/354/16/1706 on 01/21/2007

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