Back to results

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

Primary Purpose

Arteriosclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

clopidogrel (SR25990)

About this trial

This is an interventional treatment trial for Arteriosclerosis focused on measuring Embolism

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION: 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: 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

Outcomes

Primary Outcome Measures

Occurrence of myocardial infarction,stroke or cardiovascular death.

Secondary Outcome Measures

severe bleeding

Full Information

NCT ID

NCT00050817

First Posted

December 20, 2002

Last Updated

April 20, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00050817

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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.

Detailed Description

TREATMENTS: Clopidogrel (Plavix® and/or 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, diabetes…etc. PRIMARY ENDPOINT: Combined endpoint of cardiovascular mortality, stroke, acute myocardial infarction. STUDY EXECUTION: Some 7,600 patients per group will be recruited within two years. Patients will be observed over a maximum of 3.5 years. STUDY TERRITORY: Approximately 900 sites throughout North/South America, Europe, Asia, Australia, and South Africa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arteriosclerosis

Keywords

Embolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

15603 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

clopidogrel (SR25990)

Primary Outcome Measure Information:

Title

Occurrence of myocardial infarction,stroke or cardiovascular death.

Secondary Outcome Measure Information:

Title

severe bleeding

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

The Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name