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NCT00050817 · ClinicalTrials.gov registry record · Phase 3
Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 15,603
- Enrollment target
NCT00050817 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 15,603 participants.
The verdict
NCT00050817, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 15,603 participants
- Enrollment target
Study 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 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 pat
Interventions
- DRUG clopidogrel (SR25990)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15,603 participants |
| Start Date | 2002-10 |
| Est. Completion | 2005-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00050817
The ClinicalTrials.gov registry entry for NCT00050817 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 15,603 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which clopidogrel (SR25990) is the first listed.
NCT00050817 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00050817 about?
NCT00050817 is a clinical study titled "Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)". 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 plaq...
What is the current status of trial NCT00050817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 15,603 participants. The study started on 2002-10. Estimated completion is 2005-08.
What interventions are being tested in trial NCT00050817?
The interventions under investigation include: clopidogrel (SR25990) (DRUG).
Who is sponsoring clinical trial NCT00050817?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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