Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance

Complete Title of Study
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 Acronym (The trial's abbreviation if there is one)
CHARISMA

Principal Investigator, Co-investigators, and Collaborating Institutions
Study Director: ICD CSD Sanofi-Aventis

Overview of Trial
The goal of the study is to compare the efficacy of 75mg once daily clopidogrel with placebo in preventing major cardioavasular events (stroke, MI, cardiovascular death) in high risk patients on a low-dose aspirin therapy (75-162 mg daily) and to compare rates of major and fatal bleeding between the clopidogrel and placebo groups.

Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
Arteriosclerosis

Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase III

Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Arms and How They Were Treated (Intervention) (Explanation here)
None reported

Primary Pre-Specified Endpoint
Combined endpoint of cardiovascular mortality, stroke, acute myocardial infarction.

Secondary Endpoints
Severe bleeding

Inclusion Criteria

 * 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


 * and/or
 * 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

Exclusion Criteria

 * 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

Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported

Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
None reported

Conclusions of the Investigators (Quote the investigators conclusions here)
None reported

Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported

Slides
CHARISMA Slide Sets
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Video Commentary
June 8, 2007 Dr. Deepak Bhatt and Dr. C. Michael Gibson discuss the CHARISMA trial and the efficacy and safety of clopdiogrel (plavix)

References (How to insert a reference)
None reported

External sites for further information (How to insert links)
None reported

Ages
45 years and older

Gender (Indicate whether men, women or both were enrolled)
Both

Accepts Healthy Volunteers (Answer yes or no)
No

Enrollment Period (Study start and end date)
Start Date: October 2002 Completion Date: August 2005

Recruitment Status (explanation)
Completed

Enrollment (Total number of patients enrolled)
15,603

Study Sponsor (e.g. Investigator initiated or company name)
Sanofi-Aventis

Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
Sanofi-Aventis

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