Trial intelligence / Profile preview

Plavix in high-risk patients at risk of atherothrombotic events (CHARISMA)

NCT00050817Phase 3

Key facts

Status
Completed
Start
Oct 2002
Countries
32
Sponsor
Sanofi
Modality
Small Molecules
Conditions
atherothrombosis
01

Overview

Phase 3, randomised, double-blind trial in atherothrombosis comparing Clopidogrel + Aspirin with Placebo + Aspirin (2 arms). Primary endpoint: Major Adverse Cardiovascular Events at 3.5 years. Started Oct 2002; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Clopidogrel + Aspirin

    Active clopidogrel 75mg daily on top of background low-dose aspirin.

  • Placebo + Aspirin

    Matching placebo daily on top of background low-dose aspirin.

03

Endpoints

Primary

  • Major Adverse Cardiovascular Events

Secondary

  • Severe bleeding

  • Composite of CV death, MI, stroke, or hospitalization for ischemic events

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