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Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease (PAD)

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

clopidogrel (SR25990)

ticlopidine

About this trial

This is an interventional prevention trial for Peripheral Arterial Disease (PAD) focused on measuring Platelet aggregation inhibitors, Peripheral arterial disease (PAD)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clopidogrel

Ticlopidine

Arm Description

75 mg clopidogrel once daily from Day 1 to Week 12

200 mg ticlopidine once daily from Day 1 to Week 12

Outcomes

Primary Outcome Measures

Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)

Secondary Outcome Measures

Bleeding adverse events, Serious adverse events, Overall safety

Vascular events

Safety events of interest (see above)

Full Information

NCT ID

NCT00862420

First Posted

March 9, 2009

Last Updated

July 16, 2012

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00862420

Brief Title

Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease (PAD)

Keywords

Platelet aggregation inhibitors, Peripheral arterial disease (PAD)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

431 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clopidogrel

Arm Type

Experimental

Arm Description

75 mg clopidogrel once daily from Day 1 to Week 12

Arm Title

Ticlopidine

Arm Type

Active Comparator

Arm Description

200 mg ticlopidine once daily from Day 1 to Week 12

Intervention Type

Drug

Intervention Name(s)

clopidogrel (SR25990)

Intervention Description

oral administration (tablets)

Intervention Type

Drug

Intervention Name(s)

ticlopidine

Intervention Description

oral administration (tablets)

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

Bleeding adverse events, Serious adverse events, Overall safety

Time Frame

Week 12, 52 (on treatment)

Title

Vascular events

Time Frame

Week 12, 52 (on study)

Title

Safety events of interest (see above)

Time Frame

Week 52 (on treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroshi Shigematsu, Head Professor/MD/PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

23555538

Citation

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.

Results Reference

derived

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Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

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