Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050817
Status:
COMPLETED
Last Update Posted:
2012-04-23
First Post:
2002-12-20
Brief Title:
Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization Management and Avoidance CHARISMA
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE
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
OBJECTIVES
To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo in preventing cardiovascular morbiditymortality 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
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
OBJECTIVES
To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo in preventing cardiovascular morbiditymortality 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
Detailed Description:
TREATMENTS
Clopidogrel Plavix andor Iscover is an agent inhibiting platelet aggregation involved in clot formation Each tablet contains 75mg of clopidogrel A matching placebo of clopidogrel is an inactive substance that looks similar to the active clopidogrel tablet
TREATMENT PLAN
There will be two treatment groups one will receive clopidogrel 75 mg 1 tablet qd the second matching placebo of clopidogrel 1 tablet qd These study drugs will be administered on top of low-dose aspirin 75-162 mg qd systematically prescribed to such patients In addition patients enrolled in CHARISMA will be managed as appropriate for their risk factors for atherosclerosis eg high blood pressure high cholesterol diabetesetc
PRIMARY ENDPOINT
Combined endpoint of cardiovascular mortality stroke acute myocardial infarction
STUDY EXECUTION
Some 7600 patients per group will be recruited within two years Patients will be observed over a maximum of 35 years
STUDY TERRITORY
Approximately 900 sites throughout NorthSouth America Europe Asia Australia and South Africa
Clopidogrel Plavix andor Iscover is an agent inhibiting platelet aggregation involved in clot formation Each tablet contains 75mg of clopidogrel A matching placebo of clopidogrel is an inactive substance that looks similar to the active clopidogrel tablet
TREATMENT PLAN
There will be two treatment groups one will receive clopidogrel 75 mg 1 tablet qd the second matching placebo of clopidogrel 1 tablet qd These study drugs will be administered on top of low-dose aspirin 75-162 mg qd systematically prescribed to such patients In addition patients enrolled in CHARISMA will be managed as appropriate for their risk factors for atherosclerosis eg high blood pressure high cholesterol diabetesetc
PRIMARY ENDPOINT
Combined endpoint of cardiovascular mortality stroke acute myocardial infarction
STUDY EXECUTION
Some 7600 patients per group will be recruited within two years Patients will be observed over a maximum of 35 years
STUDY TERRITORY
Approximately 900 sites throughout NorthSouth America Europe Asia Australia and South Africa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None