Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral Arterial Disease (PAD)
Intervention: clopidogrel (SR25990) (Drug); ticlopidine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Hiroshi Shigematsu, Head Professor/MD/PhD, Principal Investigator, Affiliation: Second Department of Surgery (Vascular Surgery), Tokyo Medical University
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)
Secondary outcome: Bleeding adverse events, Serious adverse events, Overall safetyVascular events Safety events of interest (see above)
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis Administrative Office, Tokyo, Japan
Additional Information
Starting date: February 2009
Last updated: July 16, 2012
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