Safety Evaluation of Clopidogrel Sulfate in Patients With Stable Angina/Old Myocardial Infarction to Whom Percutaneous Coronary Intervention is Being Planned

NCT ID: NCT00821834

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1003 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-08-31

Brief Summary

Primary objective:

• To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interest in patients with stable angina (SA) or old myocardial infarction (OMI) to which percutaneous coronary intervention (PCI) is being planned.

Secondary objectives:

• To compare the incidence of adverse events, adverse drug reactions and bleeding events in patients treated with clopidogrel versus ticlopidine.
• To compare the incidence of major adverse cardiac events (MACE) and major adverse cardiac and cerebrovascular events (MACCE) in patients treated with clopidogrel versus ticlopidine.
• To evaluate the long-term safety (adverse drug reactions, adverse events, safety events of interest and bleeding events) of clopidogrel for a total of 52 weeks;
• To evaluate MACE and MACCE of clopidogrel for a total of 52 weeks.

Detailed Description

The study consisted of two periods:

• a double blind treatment period of 12 weeks followed by,
• an open label clopidogrel treatment period in a subset of patients.

All patients should receive aspirin (81-100 mg once daily) as a background therapy during investigational product administration.

Conditions

Stable Angina; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Clopidogrel

Patients received:

• clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose,
• ticlopidine matching placebo twice daily.

Group Type: EXPERIMENTAL

clopidogrel (SR25990)

Intervention Type: DRUG

Form: tablets

Route: oral

Placebo

Intervention Type: DRUG

Form: tablets

Route: oral

Ticlopidine

Patients received:

• ticlopidine 100 mg twice daily,
• clopidogrel matching placebo once daily.

Group Type: ACTIVE_COMPARATOR

ticlopidine

Intervention Type: DRUG

Form: tablets

Route: oral

Placebo

Intervention Type: DRUG

Form: tablets

Route: oral

Interventions

clopidogrel (SR25990)

Form: tablets

Route: oral

Intervention Type: DRUG

ticlopidine

Form: tablets

Route: oral

Intervention Type: DRUG

Placebo

Form: tablets

Route: oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Stable Angina / Old Myocardial Infarction patients who met all of the following criteria:

• Myocardial ischemic finding was proven within 2 months before randomization,
• Either ≥ 75% stenosis documented by CAG or severe stenosis confirmed by multi-slice computerized tomography (MSCT) angiography within 1 month before randomization,
• PCI was being planned.

Exclusion Criteria

• Planned coronary artery bypass graft (CABG), emergent/urgent PCI, or staged PCI,
• 3-vessel coronary artery disease with significant lesions in each vessel,
• Planned PCI associated with 6 or more stent placements,
• Not less than 50% stenosis of the left main coronary artery,
• Chronic total occlusion (CTO),
• Saphenous vein graft (SVG).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Takaaki Issiki, PhD/FACC

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Dpt of Medicine, Teikyo University

Locations

Sanofi-Aventis Administrative Office

Tokyo, , Japan

Countries

Japan

Other Identifiers

EFC10675

Identifier Type: -

Identifier Source: org_study_id