Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance
Complete Title of Study
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)
Study Acronym (The trial’s abbreviation if there is one)
CHARISMA
Principal Investigator, Co-investigators, and Collaborating Institutions
Principal Investigator, Co-investigators, and Collaborating Institutions
Study Director: ICD CSD Sanofi-Aventis
Overview of Trial
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.)
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
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase III
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Phase I Trials
These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.
Phase II Trials
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.
Phase III Trials
Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.
Phase IV Trials
After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug’s risks,benefits, and optimal use in a broader group of real world patients.
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
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)
Study Arms and How They Were Treated (Intervention) (Explanation here)
None reported
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
In a clinical study, participants are often divided into groups.
In interventional studies, participants are prospectively assigned to arms and receive different interventions. Assignment to an arm is typically random. Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect.
In observational studies, a pre-defined population may be observed over time and is termed, a cohort. A cohort consists of individuals with some common characteristic(s), for example, age, place of residence/employment, or medical condition. A cohort is observed over time to determine if the presence or absence of an exposure is associated with a health outcome or condition. Other observational studies may compare those with a condition (cases) to those without a condition (control) and evaluate differences in exposures, treatments, or behaviors. The cases and controls may be selected from a larger population or a cohort.
Source
Primary Pre-Specified Endpoint
Primary Pre-Specified Endpoint
Combined endpoint of cardiovascular mortality, stroke, acute myocardial infarction.
Secondary Endpoints
Secondary Endpoints
Severe bleeding
Inclusion Criteria
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
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)
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)
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)
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)
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)
Conclusions of the Investigators (Quote the investigators conclusions here)
None reported
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported
Video Commentary
Video Commentary
External sites for further information (How to insert links)
External sites for further information (How to insert links)
None reported
Detailed information about the trial
Detailed information about the trial
Ages
Ages
45 years and older
Gender (Indicate whether men, women or both were enrolled)
Gender (Indicate whether men, women or both were enrolled)
Both
Accepts Healthy Volunteers (Answer yes or no)
Accepts Healthy Volunteers (Answer yes or no)
No
Enrollment Period (Study start and end date)
Enrollment Period (Study start and end date)
Start Date: October 2002 Completion Date: August 2005
Recruitment Status (explanation)
Recruitment Status (explanation)
Completed
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Recruitment status indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:
- Not yet recruiting: participants are not yet being recruited or enrolled
- Recruiting: participants are currently being recruited and enrolled
- Enrolling by invitation: participants are being (or will be) selected from a predetermined population
- Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
- Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
- Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
- Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
- Withdrawn: study halted prematurely, prior to enrollment of first participant
Enrollment (Total number of patients enrolled)
Enrollment (Total number of patients enrolled)
15,603
Study Sponsor (e.g. Investigator initiated or company name)
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)
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
Sanofi-Aventis
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