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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


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 safety

Vascular events

Safety events of interest (see above)


Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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