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Trial details imported from ClinicalTrials.gov
Ethics application status
Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)
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.
Universal Trial Number (UTN)
Diseases of the vasculature and circulation including the lymphatic system
Description of intervention(s) / exposure
Treatment: Drugs - clopidogrel (SR25990)
Treatment: Drugs: clopidogrel (SR25990)
Intervention code 
Comparator / control treatment
Primary outcome 
Occurrence of myocardial infarction,stroke or cardiovascular death.
Secondary outcome 
Key inclusion criteria
Be at least 45 years old and comply with at least one of the four categories of inclusion
- 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
- 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
Both males and females
Can healthy volunteers participate?
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Sanofi-aventis Administrative Office - Macquarie Park
Recruitment postcode(s) 
United States of America
Primary sponsor type
Ethics application status
- 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.
Trial related presentations / publications