Clopidogrel For High Atherothrombotic Risk, Ischemic Stabilization, Management, And Avoidance: Difference between revisions
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== 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 <small>(The trial's abbreviation if there is one) </small>== | ==Study Acronym <small>(The trial's abbreviation if there is one) </small>== | ||
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 <small>(e.g. acute MI, breast cancer, etc.)</small>== | ==Disease State(s) Studied <small>(e.g. acute MI, breast cancer, etc.)</small>== | ||
Arteriosclerosis | |||
==Study Phase <small>(e.g. Phase I,II,III,IV) [[Study phase|Study Phases are defined here]]</small>== | ==Study Phase <small>(e.g. Phase I,II,III,IV) [[Study phase|Study Phases are defined here]]</small>== | ||
Phase III | |||
==Study Design <small>(e.g. multicenter, randomized, double blind, placebo controlled)</small>== | ==Study Design <small>(e.g. multicenter, randomized, double blind, placebo controlled)</small>== | ||
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | |||
== Study Arms and How They Were Treated (Intervention) <small>[[Study arms|(Explanation here)]]</small>== | == Study Arms and How They Were Treated (Intervention) <small>[[Study arms|(Explanation here)]]</small>== | ||
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== 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 <small>(Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)</small>== | ==Outcome: Primary endpoint <small>(Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)</small>== |
Revision as of 14:20, 10 June 2009
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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
None reported
Video Commentary
None reported
References (How to insert a reference)
None reported
External sites for further information (How to insert links)
None reported
Detailed information about the trial
Ages
__ years to ___ years
Gender (Indicate whether men, women or both were enrolled)
None reported
Accepts Healthy Volunteers (Answer yes or no)
None reported
Enrollment Period (Study start and end date)
None reported
Recruitment Status (explanation)
None reported
Enrollment (Total number of patients enrolled)
None reported
Study Sponsor (e.g. Investigator initiated or company name)
None reported (this may not have yet been ascertained)
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
None reported
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