NCT00821834

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,003 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	clopidogrel (SR25990)	Form: tablets Route: oral
DRUG	ticlopidine	Form: tablets Route: oral
DRUG	Placebo	Form: tablets Route: oral

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-01-14
• Last updated: 2011-07-26

Locations

1 site across 1 country: Japan