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Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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