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.)
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)