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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stable Angina; Myocardial Infarction

Intervention: clopidogrel (SR25990) (Drug); ticlopidine (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Takaaki Issiki, PhD/FACC, Principal Investigator, Affiliation: Division of Cardiology, Dpt of Medicine, Teikyo University

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.

Clinical Details

Official title: A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg Once Daily With a 300 mg Loading Dose Versus Ticlopidine 100 mg Twice Daily in Patients With Stable Angina or Old (Healed) Myocardial Infarction to Which Percutaneous Coronary Intervention is Being Planned - With Extended Treatment of Clopidogrel 75 mg Once Daily for 40 Weeks in a Patients' Subset

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Time from randomization to first safety events of interest

Secondary outcome:

Time from randomization to first Major Adverse Cardiac Events (MACE)

Time from randomization to first bleeding events

Time from randomization to first Adverse Events / Adverse Drug Reactions

Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)

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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Tokyo, Japan
Additional Information

Starting date: December 2008
Last updated: July 25, 2011

Page last updated: August 23, 2015

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