This site is intended for healthcare professionals

Go to /sign-in page

You can view 5 more pages before signing in

CHARISMA

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

  • CHARISMA (Clopidogrel for High Athero-thrombotic Risk and Ischemic Stabilization, Management, and Avoidance) study found that, in a broad population of patients at high risk of cardiovascular (CV) events, clopidogrel plus aspirin was no more effective than aspirin alone in preventing major CV events
    • a double-blind, randomised, placebo-controlled trial of 15,603 patients (median age 64, 30% women) with either clinically evident (78%), or multiple risk factors for, CV disease. Patients received low-dose aspirin (75 to 162mg daily) or low-dose aspirin plus clopidogrel (75mg daily) and were followed-up for a median of 28 months
    • the use of clopidogrel was associated with an increased the risk of moderate bleeding
      • no significant difference in severe bleeding between the groups (1.7% clopidogrel plus aspirin vs. 1.3% aspirin, P=0.09), the risk of moderate bleeding was significantly higher in the clopidogrel plus aspirin group (2.1% vs. 1.3%, P<0.001, number needed to harm [NNH] 125)
    • proportion of patients who suffered a primary outcome event (myocardial infarction [MI], stroke, or death from CV causes) was similar in both groups (clopidogrel plus aspirin 6.8% vs. aspirin 7.3%, P=0.22)
      • clopidogrel was associated with a small reduction in primary outcomes in patients who had existing CV disease (6.9% vs. 7.9%, P=0.046, number needed to treat 100). However, in asymptomatic patients it increased the risk of death from CV causes (3.9% vs. 2.2%, P=0.01, NNH 59) and from any cause (5.4% vs. 3.8%, P=0.04, NNH 63)
      • it has been stated that these subgroup analyses should only be regarded as a basis for future research and not as a reason to change practice
    • the study authors concluded (1) "...there was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors. Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes.."
    • a MeReC Extra review states that "...Clopidogrel plus aspirin has shown benefit in the acute treatment of patients following an MI. However, the CHARISMA study does not support the general use of clopidogrel plus aspirin for subsequent prevention of CV events, or for primary prevention in high-risk patients.."
    • a further analysis of the CHARISMA data revealed (4):
      • findings do not support the use of dual-antiplatelet therapy with clopidogrel and aspirin in a primary prevention population. In this subgroup analysis, CV death occurred more frequently than anticipated
        • cause of this apparent harm is not elucidated, may represent play of chance, but requires further prospective evaluation

Reference:


Create an account to add page annotations

Add information to this page that would be handy to have on hand during a consultation, such as a web address or phone number. This information will always be displayed when you visit this page

The content herein is provided for informational purposes and does not replace the need to apply professional clinical judgement when diagnosing or treating any medical condition. A licensed medical practitioner should be consulted for diagnosis and treatment of any and all medical conditions.

Connect

Copyright 2024 Oxbridge Solutions Limited, a subsidiary of OmniaMed Communications Limited. All rights reserved. Any distribution or duplication of the information contained herein is strictly prohibited. Oxbridge Solutions receives funding from advertising but maintains editorial independence.