Clinical trial NCT00862420: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Arterial Disease (PAD)
Keywords: Platelet aggregation inhibitors
Peripheral arterial disease (PAD)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-03-16
Enrollment: 431
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
timeFrame: Week 12 (on treatment)
Secondary outcomes:
measure: Bleeding adverse events, Serious adverse events, Overall safety
timeFrame: Week 12, 52 (on treatment)
measure: Vascular events
timeFrame: Week 12, 52 (on study)
measure: Safety events of interest (see above)
timeFrame: Week 52 (on treatment)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Second Department of Surgery (Vascular Surgery), Tokyo Medical University
name: Hiroshi Shigematsu, Head Professor/MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.