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

Phase 3

Completed

• Conditions: Stable Angina; Myocardial Infarction
• Interventions: Drug: clopidogrel (SR25990); Drug: ticlopidine; Drug: Placebo

• Registration Number: NCT00821834
• Lead Sponsor: Sanofi

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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	clopidogrel (SR25990)	Patients received: * clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose, * ticlopidine matching placebo twice daily.
Clopidogrel	Placebo	Patients received: * clopidogrel 300 mg as a loading dose, then 75 mg once daily as a maintenance dose, * ticlopidine matching placebo twice daily.
Ticlopidine	Placebo	Patients received: * ticlopidine 100 mg twice daily, * clopidogrel matching placebo once daily.
Ticlopidine	ticlopidine	Patients received: * ticlopidine 100 mg twice daily, * clopidogrel matching placebo once daily.

Primary Outcome Measures

Name	Time	Method
Time from randomization to first safety events of interest	12 Weeks (duble blind treatment period)	Safety events of interest were: * Clinically significant bleeding,; * Leukopenia, neutropenia or thrombocytopenia occurring as adverse drug reaction,; * Elevated liver function values occurring as adverse drug reaction,; * Permanent investigational product discontinuation due to skin disorders, gastrointestinal disorders, bleeding, hepatic disorders, or significant decreases in such tests as leukocytes, neutrophils or platelets occurring as adverse drug reaction.

Secondary Outcome Measures

Name	Time	Method
Time from randomization to first Major Adverse Cardiac Events (MACE)	12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)	MACE included: * All- cause mortality,; * Acute myocardial infarction,; * Revascularization (excluding revascularization related to the planned PCI),; * Stent thrombosis
Time from randomization to first bleeding events	12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Adverse Events / Adverse Drug Reactions	12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)	12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)	MACCE included: * All- cause mortality,; * Acute myocardial infarction,; * Revascularization (excluding revascularization related to the planned PCI),; * Stent thrombosis,; * Ischemic stroke.

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇯🇵 Tokyo, Japan