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The CLASSICS trial: study design

The CLASSICS trial: study design. 8 European countries, 48 centres. D1. D2 to D28. Clopidogrel 75mg od Aspirin 325mg od. Clopidogrel 300mg od Aspirin 325mg od. Double-blind randomisation. Clopidogrel 75mg od Aspirin 325mg od. Clopidogrel 75mg od Aspirin 325mg od. Stent implantation.

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The CLASSICS trial: study design

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  1. The CLASSICS trial: study design • 8 European countries, 48 centres D1 D2 to D28 Clopidogrel 75mg odAspirin 325mg od Clopidogrel 300mg odAspirin 325mg od Double-blind randomisation Clopidogrel 75mg odAspirin 325mg od Clopidogrel 75mg odAspirin 325mg od Stentimplantation n = 1005 Ticlopidine 250mg bidAspirin 325mg od Ticlopidine 250mg bidAspirin 325mg od

  2. Principal criteria Major peripheral or bleeding complications Neutropaenia Thrombocytopaenia EPD for non-cardiac adverse events The CLASSICS trialPrimary assessment: safety Secondary criteria Occurrence of adverse events grouped by category Values and change from baseline of laboratory parameters

  3. The CLASSICS trialSecondary assessment: efficacy • Global mortality • Incidence of major cardiac events • Cardiovascular death • Myocardial infarction • Target lesion revascularisation • Prevention of subacute thrombosis after coronary stenting

  4. The CREDO trial: study design Double-blind, comparison between two regimens2000 patients, 100 centres in the USA 1 YEAR 1 MONTH PTCA Placebo +aspirin Clopidogrel 75 mg+ aspirin Placebo + aspirin Clopidogrel300 mgloading dose+ aspirin Clopidogrel 75 mg + aspirin 6-24 h before PTCA

  5. Clopidogrel for coronary stenting: current status • Use of stenting in coronary angioplasty is increasing • Complementary antithrombotic and antiplatelet therapies are becoming established to reduce the risk of subacute thrombosis after coronary stenting • Ticlopidine + aspirin have proven antiplatelet efficacy in coronary stenting • The CLASSICS trial compares the safety of ticlopidine + aspirin with clopidogrel (with and without a loading dose) + aspirin for coronary stenting • The CREDO trial is underway to assess the efficacy of clopidogrel + aspirin at 30 days and 1 year following PTCA, with or without stenting

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