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

Myocardial Infarction Clinical Trial

— CLEAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821834
• Other study ID #: EFC10675
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2009
• Last updated: July 25, 2011
• Start date: December 2008
• Est. completion date: August 2010

Study information

• Verified date: July 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1003
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Infarction
• Myocardial Infarction
• Stable Angina

Intervention

Drug:
• clopidogrel (SR25990)
Form: tablets Route: oral
• ticlopidine
Form: tablets Route: oral
• Placebo
Form: tablets Route: oral

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from randomization to first safety events of interest	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.	12 Weeks (duble blind treatment period)	Yes
Secondary	Time from randomization to first Major Adverse Cardiac Events (MACE)	MACE included: All- cause mortality,; Acute myocardial infarction,; Revascularization (excluding revascularization related to the planned PCI),; Stent thrombosis	12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)	No
Secondary	Time from randomization to first bleeding events		12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)	Yes
Secondary	Time from randomization to first Adverse Events / Adverse Drug Reactions		12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)	Yes
Secondary	Time from randomization to first Major Adverse Cardiac and Cerebrovascular Events (MACCE)	MACCE included: All- cause mortality,; Acute myocardial infarction,; Revascularization (excluding revascularization related to the planned PCI),; Stent thrombosis,; Ischemic stroke.	12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)	No