NCT00050817|CompletedPhase 3

Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA)

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.

Sanofi ClinicalTrials.gov

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1 other identifier

EFC4505

Study Type

interventional

Target

15,603

Locations

31 countries

Sites

Timeline

RegisteredDec 2002

StartedOct 2002

CompletionAug 2005

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 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 patient population.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

15,603

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Oct 2002

Typical duration for phase_3

Geographic Reach

31 countries

31 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

October 1, 2002

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2002

Completed

3 days until next milestone

First Posted

Study publicly available on registry

December 23, 2002

Completed

2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed

Last Updated

April 23, 2012

Status Verified

April 1, 2012

First QC Date

December 20, 2002

Last Update Submit

April 20, 2012

Conditions

Arteriosclerosis

Keywords

Embolism

Outcome Measures

Primary Outcomes (1)

Occurrence of myocardial infarction,stroke or cardiovascular death.

Secondary Outcomes (1)

severe bleeding

Interventions

clopidogrel (SR25990)DRUG

Eligibility Criteria

Age45 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+2 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sanofilead