Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Sanofi

Status and phase: Completed; Phase 3

Conditions: Peripheral Arterial Disease (PAD)

Treatments: Drug: ticlopidine; Drug: clopidogrel (SR25990)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00862420

SFY10810

Details and patient eligibility

About

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

Enrollment: 431 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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431 participants in 2 patient groups

Clopidogrel

Experimental group

Description:

75 mg clopidogrel once daily from Day 1 to Week 12

Treatment:

Drug: clopidogrel (SR25990)

Ticlopidine

Active Comparator group

Description:

200 mg ticlopidine once daily from Day 1 to Week 12

Treatment:

Drug: ticlopidine