The Clopidogrel Aspirin Stent International Cooperative Study (CLASSICS) - CLASSICS

Description:

Double-Blinded Study of the Safety of Clopidogrel With and Without A Loading Dose in Combination With Aspirin Compared With Ticlopidine in Combination With Aspirin After Coronary Stenting: The Clopidogrel Aspirin Stent International Cooperative Study (CLASSICS)

Hypothesis:

To determine the relative safety of clopidogrel with and without a loading dose plus aspirin compared to ticlopidine plus aspirin in patients undergoing coronary stenting.

Study Design

Study Design:

Patients Enrolled: 1,020

Drug/Procedures Used:

1,020 patients who had undergone successful coronary stenting were randomized to receive for 28 days ticlopidine (250mg BID) plus aspirin (325 mg/d), clopidogrel (75 mg/d) plus aspirin (325 mg/d), or a loading dose of clopidogrel (300mg) followed by clopidogrel (75 mg/d) plus aspirin (325 mg/d). The primary endpoint was a composite of major peripheral or bleeding complications, neutropenia, thrombocytopenia or early discontinuation of the drug because of a non-cardiac event. The secondary endpoint included cardiovascular death, any MI and target vessel revascularization.

Principal Findings:

The primary endpoint occurred in 9.1% of patients in the ticlopidine group, 6.35% of patients in the 75 mg/d clopidogrel group, and in 2.9% of patients in the clopidogrel loading-dose group (4.6% incidence in the combined clopidogrel group, a 50% relative risk reductin when compared to ticlopidine, p<0.005). There were no significant differences among the three groups in the incidence of the secondary endpoints (respectively 0.9%, 1.5% and 1.2% of patients). There were only two deaths (one sudden and one associated with an MI), both occurring in the clopidogrel loading-dose group. MI rates were low: 0.58% in the ticlopidine group, 1.2% in the clopidogrel 75 mg/d group and 0.86% in the clopidogrel loading-dose group.

Clopidogrel appears to have superior safety and tolerability compared with ticlopidine and acceptable efficacy in the prevention of major adverse cardiac events following coronary stenting.

Interpretation:

Although this study was not developed to determine efficacy, the results support the use of clopidogrel as an alternative to ticlopidine after coronary stenting.

References:

1. Bertrand ME, Rupprecht HJ, Urban P, et al. Circulation 2000;102:624-29.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Interventions and Coronary Artery Disease

Keywords: Neutropenia, Risk, Coronary Artery Disease, Platelet Aggregation Inhibitors, Ticlopidine, Thrombocytopenia, Stents


< Back to Listings