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Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00050817
Recruitment Status : Completed
First Posted : December 23, 2002
Last Update Posted : April 23, 2012
Information provided by:

Brief Summary:


  • Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
  • In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
  • The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.


  • To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
  • To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.

Condition or disease Intervention/treatment Phase
Arteriosclerosis Drug: clopidogrel (SR25990) Phase 3

Detailed Description:


  • Clopidogrel (Plavix® and/or Iscover®) is an agent inhibiting platelet aggregation involved in clot formation. Each tablet contains 75mg of clopidogrel. A matching placebo of clopidogrel is an inactive substance that looks similar to the active clopidogrel tablet.


  • There will be two treatment groups; one will receive clopidogrel 75 mg (1 tablet qd), the second matching placebo of clopidogrel (1 tablet qd). These study drugs will be administered on top of low-dose aspirin (75-162 mg qd) systematically prescribed to such patients. In addition, patients enrolled in CHARISMA will be managed as appropriate for their risk factors for atherosclerosis: eg. high blood pressure, high cholesterol, diabetes…etc.


  • Combined endpoint of cardiovascular mortality, stroke, acute myocardial infarction.


  • Some 7,600 patients per group will be recruited within two years. Patients will be observed over a maximum of 3.5 years.


  • Approximately 900 sites throughout North/South America, Europe, Asia, Australia, and South Africa.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15603 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.
Study Start Date : October 2002
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Occurrence of myocardial infarction,stroke or cardiovascular death.

Secondary Outcome Measures :
  1. severe bleeding

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


Be at least 45 years old and comply with at least one of the four categories of inclusion criteria:

  • Combination of atherothrombotic risk factors (2 major or 3 minor or 1 major + 2 minor risk factors among those listed below)

Major atherothrombotic risk factors

  • Type I or II diabetes (under drug therapy)
  • Diabetic nephropathy
  • Ankle brachial index (ABI) < 0.9
  • Asymptomatic carotid stenosis >= 70%
  • At least one carotid plaque as evidenced by intima-media thickness (IMT)

Minor atherothrombotic risk factors

  • Systolic blood pressure (SBP) >= 150 mmHg, despite appropriate therapy for at least 3 months
  • Primary hypercholesterolemia
  • Current smoking > 15 cigarettes per day
  • Male >= 65 years
  • Female >= 70 years


  • Documented cerebrovascular disease (TIA or IS within 5 years) and/or
  • Documented coronary artery disease (stable angina with documented multivessel coronary disease, previous documented MI, multivessel PCI or CABG within 1 year, multivessel CABG older than 1 year associated with current angina) and/or
  • Documented symptomatic PAD


  • Absolute indication for the use of clopidogrel, high-dose aspirin (>162 mg), NSAIDs, or oral anti-thrombotic drugs
  • Absolute contraindication to the use of clopidogrel or aspirin
  • Clinical conditions likely to interfere with follow-up leading to inability to complete the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050817

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United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sanofi-aventis Administrative Office
Buenos Aires, Argentina
Sanofi-aventis Administrative Office
Macquarie Park, Australia
Sanofi-aventis Administrative Office
Wien, Austria
Sanofi-aventis Administrative Office
Diegem, Belgium
Sanofi-aventis Administrative Office
Sao Paulo, Brazil
Sanofi-aventis Administrative Office
Laval, Canada
Sanofi-aventis Administrative Office
Santiago, Chile
Czech Republic
Sanofi-aventis Administrative Office
Praha, Czech Republic
Sanofi-aventis Administrative Office
Horsholm, Denmark
Sanofi-aventis Administrative Office
Helsinki, Finland
Sanofi-aventis Administrative Office
Paris, France
Sanofi-aventis Administrative Office
Berlin, Germany
Sanofi-aventis Administrative Office
Athens, Greece
Hong Kong
Sanofi-aventis Administrative Office
Causeway Bay, Hong Kong
Sanofi-aventis Administrative Office
Budapest, Hungary
Sanofi-aventis Administrative Office
Milano, Italy
Sanofi-aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-aventis Administrative Office
Mexico, Mexico
Sanofi-aventis Administrative Office
Gouda, Netherlands
Sanofi-aventis Administrative Office
Lysaker, Norway
Sanofi-aventis Administrative Office
Warszawa, Poland
Sanofi-aventis Administrative Office
Porto Salvo, Portugal
Russian Federation
Sanofi-aventis Administrative Office
Moscow, Russian Federation
Sanofi-aventis Administrative Office
Singapore, Singapore
South Africa
Sanofi-aventis Administrative Office
Midrand, South Africa
Sanofi-aventis Administrative Office
Barcelona, Spain
Sanofi-aventis Administrative Office
Bromma, Sweden
Sanofi-aventis Administrative Office
Geneva, Switzerland
Sanofi-aventis Administrative Office
Taipei, Taiwan
Sanofi-aventis Administrative Office
Istanbul, Turkey
United Kingdom
Sanofi-aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00050817    
Other Study ID Numbers: EFC4505
First Posted: December 23, 2002    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012
Keywords provided by Sanofi:
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs