Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Phase 3

Completed

• Conditions: Peripheral Arterial Disease (PAD)
• Interventions: Drug: clopidogrel (SR25990); Drug: ticlopidine

• Registration Number: NCT00862420
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-13
• Study First Posted: 2009-03-16
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 431

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clopidogrel	clopidogrel (SR25990)	75 mg clopidogrel once daily from Day 1 to Week 12
Ticlopidine	ticlopidine	200 mg ticlopidine once daily from Day 1 to Week 12

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vascular events	Week 12, 52 (on study)
Safety events of interest (see above)	Week 52 (on treatment)
Bleeding adverse events, Serious adverse events, Overall safety	Week 12, 52 (on treatment)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇯🇵 Tokyo, Japan