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

July 25, 2011 updated by: Sanofi

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

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

1003

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tokyo, Japan
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clopidogrel

Patients received:

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

Form: tablets

Route: oral

Form: tablets

Route: oral

Active Comparator: Ticlopidine

Patients received:

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

Form: tablets

Route: oral

Form: tablets

Route: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from randomization to first safety events of interest
Time Frame: 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.
12 Weeks (duble blind treatment period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from randomization to first Major Adverse Cardiac Events (MACE)
Time Frame: 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
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first bleeding events
Time Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
Time from randomization to first Adverse Events / Adverse Drug Reactions
Time Frame: 12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)
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)
Time Frame: 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.
12 Weeks (double-blind treatment period) , 52 weeks (double-blind + open label treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Takaaki Issiki, PhD/FACC, Division of Cardiology, Dpt of Medicine, Teikyo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

July 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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