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January 1, 1996Thrombosis and Haemostasis

Platelet Anti-Aggregating Activity and Tolerance of Clopidogrel in Atherosclerotic Patients

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Why the study?

Does clopidogrel dose-dependently inhibit platelet aggregation compared to ticlopidine or placebo in atherosclerotic patients?

Population

150 ambulatory patients suffering from vascular manifestations of atherosclerosis

Comparison

Clopidogrel at doses of 10, 25, 50, 75 or 100 mg… vs Ticlopidine 250 mg twice daily or placebo

Design

RCT, randomized into one of the seven following groups

Follow-up

28 days

Authors

BBB BoneuCentre National de la Recherche Scientifique GDG. DestelleSanofi (France)

Discussion

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Implication

Supports 75 mg daily dosing for CAPRIE; extends dose-response data to guide secondary prevention trials.

Key Points

To identify the optimal clopidogrel dose for secondary prevention of ischemic events by assessing its antiplatelet activity and tolerability relative to ticlopidine and placebo.
Multicenter randomized trial across 29 clinical centers and 9 haematological laboratories including 150 ambulatory atherosclerotic patients.
Patients were randomized to seven groups receiving clopidogrel (10, 25, 50, 75, or 100 mg once daily), ticlopidine (250 mg twice daily), or placebo.
Bleeding time was measured on days 0 and 28, while tolerability and platelet aggregation induced by ADP and collagen were assessed on days 0, 7, and 28.
Clopidogrel caused dose-dependent inhibition of 5 µM ADP-induced platelet aggregation (29% to 44% reduction from baseline) and prolonged bleeding time by 1.5 to 1.7 times.
Platelet aggregation inhibition and bleeding time extension with clopidogrel were not significantly different from the effects produced by ticlopidine.
Clinical tolerability was good or fair in 97.5% of patients with zero haematological adverse events recorded, confirming the selection of 75 mg once daily for the CAPRIE trial.

Structured PICO

Does clopidogrel dose-dependently inhibit platelet aggregation compared to ticlopidine or placebo in atherosclerotic patients?

P

Population

150 ambulatory patients suffering from vascular manifestations of atherosclerosis

I

Intervention

Clopidogrel at doses of 10, 25, 50, 75 or 100 mg once daily for 28 days

C

Comparator

Ticlopidine 250 mg twice daily or placebo

O

Outcome

ADP and collagen-induced platelet aggregation tests and bleeding time at 7 and 28 dayssurrogate

Clopidogrel demonstrated dose-dependent platelet inhibition comparable to ticlopidine with good tolerability, establishing 75 mg once daily as the optimal dose for the CAPRIE trial.

Cite This Study

Boneu et al. (1996) studied this question.

synapsesocial.com/papers/6a89b870755d28965dfd5245 https://doi.org/10.1055/s-0038-1650689

Topics

Dual antiplatelet therapy Women and heart disease

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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee1996
2Effect of Clopidogrel on Platelet Aggregation and Plasma Concentration of Fibrinogen in Subjects with Cerebral or Coronary Atherosclerotic Disease2002 · 19 citations
3Antiplatelet Activity of Clopidogrel in Coronary Artery Bypass Graft Surgery Patients1999 · 21 citations
4Loading, Pretreatment, and Interindividual Variability Issues With Clopidogrel Dosing2005 · 42 citations
5ANTIPLATELET ADEQUACY OF CYCLOPENTYL TRIAZOLOPYRIMIDINE VERSUS CLOPIDOGREL IN-PATIENTS WITH CORONARY HEART DISEASE2018 · 7 citations