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Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

NCT ID: NCT00862420

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

431 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Peripheral Arterial Disease (PAD)

Keywords

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Platelet aggregation inhibitors Peripheral arterial disease (PAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clopidogrel

75 mg clopidogrel once daily from Day 1 to Week 12

Group Type EXPERIMENTAL

clopidogrel (SR25990)

Intervention Type DRUG

oral administration (tablets)

Ticlopidine

200 mg ticlopidine once daily from Day 1 to Week 12

Group Type ACTIVE_COMPARATOR

ticlopidine

Intervention Type DRUG

oral administration (tablets)

Interventions

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clopidogrel (SR25990)

oral administration (tablets)

Intervention Type DRUG

ticlopidine

oral administration (tablets)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hiroshi Shigematsu, Head Professor/MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Second Department of Surgery (Vascular Surgery), Tokyo Medical University

Locations

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Sanofi-Aventis Administrative Office

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Shigematsu H, Komori K, Tanemoto K, Harada Y, Nakamura M. Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients. Ann Vasc Dis. 2012;5(3):364-75. doi: 10.3400/avd.oa.12.00039.

Reference Type DERIVED
PMID: 23555538 (View on PubMed)

Other Identifiers

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SFY10810

Identifier Type: -

Identifier Source: org_study_id