¨ 8 European countries, 48 centres Stent implantation Double-blind randomisation n = 1005 Clopidogrel 300mg od Aspirin 325mg od Clopidogrel 75mg od Aspirin 325mg od Ticlopidine 250mg bid Aspirin 325mg od Clopidogrel 75mg od Aspirin 325mg od D1 D2 to D28 The CLASSICS trial: study design Ticlopidine 250mg bid Aspirin 325mg od
The CLASSICS trial Primary assessment: safety Principal criteria Major peripheral or bleeding complications Neutropaenia Thrombocytopaenia EPD for non-cardiac adverse events Secondary criteria Occurrence of adverse events grouped by category Values and change from baseline of laboratory parameters
The CLASSICS trial Secondary assessment: efficacy ¨Global mortality ¨Incidence of major cardiac events – Cardiovascular death – Myocardial infarction – Target lesion revascularisation ¨Prevention of subacute thrombosis after coronary stenting
Double-blind, comparison between two regimens 2000 patients, 100 centres in the USA PTCA 1 MONTH 1 YEAR Placebo + aspirin Clopidogrel 75 mg + aspirin Placebo + aspirin Clopidogrel 75 mg + aspirin 6-24 h before PTCA The CREDO trial: study design Clopidogrel 300 mg loading dose + aspirin
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