Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

July 16, 2012 updated by: Sanofi

A Randomized, Double Blind, Parallel Group Study to Investigate the Safety of 12 Weeks of Clopidogrel 75 mg/Day Versus Ticlopidine 200 mg/Day in Patients With Peripheral Arterial Disease - With Extended Treatment of Clopidogrel 75 mg/Day for 40 Weeks

Primary objective:

  • To evaluate whether 12 weeks of clopidogrel is superior to ticlopidine in terms of lower risk of the safety events of interests in patients with peripheral arterial disease (PAD)

Secondary objectives:

  • To compare the risk of bleeding adverse events, serious adverse events and overall safety of clopidogrel with ticlopidine
  • To compare the risk of vascular events of clopidogrel with ticlopidine
  • To document the long-term safety of clopidogrel for a total of 52 weeks
  • To document the vascular events of clopidogrel for a total of 52 weeks

Study Overview

Study Type

Interventional

Enrollment (Actual)

431

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:

Documented symptomatic peripheral arterial disease (one or both of the following two primary criteria must be satisfied):

  • Current intermittent claudication with Ankle Brachial Index (ABI) < 0.90
  • A history of intermittent claudication together with previous related intervention in a leg

Exclusion Criteria:

  • Patients who had acute atherothrombotic events or any invasive therapies within 30 days before the randomization, or patients who planned any invasive therapies within 12 weeks after the randomization
  • Bleeding diathesis, coagulopathy and present bleeding disease
  • Previous intracranial bleeding or hemorrhagic stroke
  • Uncontrolled hypertension

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
75 mg clopidogrel once daily from Day 1 to Week 12
oral administration (tablets)
Active Comparator: Ticlopidine
200 mg ticlopidine once daily from Day 1 to Week 12
oral administration (tablets)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
Time Frame: Week 12 (on treatment)
Week 12 (on treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding adverse events, Serious adverse events, Overall safety
Time Frame: Week 12, 52 (on treatment)
Week 12, 52 (on treatment)
Vascular events
Time Frame: Week 12, 52 (on study)
Week 12, 52 (on study)
Safety events of interest (see above)
Time Frame: Week 52 (on treatment)
Week 52 (on treatment)

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Hiroshi Shigematsu, Head Professor/MD/PhD, Second Department of Surgery (Vascular Surgery), Tokyo Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

February 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 13, 2009

First Posted (Estimate)

March 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

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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