Double-blind study of the safety of clopidogrel with and without a loadingdose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting - The Clopidogrel Aspirin Stent International Cooperative Study (CLASSICS)
Me. Bertrand et al., Double-blind study of the safety of clopidogrel with and without a loadingdose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting - The Clopidogrel Aspirin Stent International Cooperative Study (CLASSICS), CIRCULATION, 102(6), 2000, pp. 624-629
Citations number
19
Categorie Soggetti
Cardiovascular & Respiratory Systems","Cardiovascular & Hematology Research
Background-Combination therapy with the ADP receptor antagonist ticlopidine
pins aspirin has emerged as standard care after coronary stenting. Clopido
grel, a new ADP receptor antagonist, has greater molar potency than ticlopi
dine and better safety/tolerability.
Methods and Results Patients (n=1020) were randomized after successful sten
t placement and initiated on a 28-day regimen of either (1) 300-mg clopidog
rel loading dose and 325 mg/d aspirin on day 1, followed by 75 mg/d clopido
grel and 325 mg/d aspirin; (2) 75 mg/d clopidogrel and 325 mg/d aspirin: or
(3) 250 mg BID ticlopidine and 325 mg/d aspirin. The primary end point con
sisted of major peripheral or bleeding complications, neutropenia, thromboc
ytopenia or early discontinuation of study drug as the result of a noncardi
ac adverse event during the study-drug treatment period. The primary end po
int occurred in 9.1% of patients (n=31) in the ticlopidine group and 4.6% o
f patients (n=31) in the combined clopidogrel group (relative risk 0.50; 95
% Cl 0.31 to 0.81; P=0.005). Overall rates of major adverse cardiac events
(cardiac death, myocardial infarction, target lesion revascularization) wer
e low and comparable between treatment groups (0.9% with ticlopidine, 1.5%
with 75 mg/d clopidogrel, 1.2% with the clopidogrel loading dose; P=NS for
all comparisons).
Conclusions-The safety/tolerability of clopidogrel (plus aspirin) is superi
or to that of ticlopidine (plus aspirin) (P=0.005). The 300-mg loading dose
was well tolerated, notably with no increased risk of bleeding. Secondary
end point data an consistent with the hypothesis that clopidogrel and ticlo
pidine have comparable efficacy with regard to cardiac events after success
ful stenting.