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OpenTrials
Completed

NCT Number: NCT00862420

Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

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

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Key information

Conditions

Peripheral Arterial Disease (PAD) Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

clopidogrel (SR25990)

Drug

oral administration (tablets)

ticlopidine

Drug

oral administration (tablets)

Primary outcomes

  1. 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 outcomes

  1. Bleeding adverse events, Serious adverse events, Overall safety

    Time frame: Week 12, 52 (on treatment)

  2. Vascular events

    Time frame: Week 12, 52 (on study)

  3. Safety events of interest (see above)

    Time frame: Week 52 (on treatment)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2009
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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