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Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00862420
First received: March 9, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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

Condition Intervention Phase
Peripheral Arterial Disease (PAD)
 Drug: clopidogrel (SR25990)
Drug: ticlopidine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Bleeding adverse events, Serious adverse events, Overall safety [ Time Frame: Week 12, 52 (on treatment) ] [ Designated as safety issue: Yes ]
  • Vascular events [ Time Frame: Week 12, 52 (on study) ] [ Designated as safety issue: No ]
  • Safety events of interest (see above) [ Time Frame: Week 52 (on treatment) ] [ Designated as safety issue: Yes ]

Enrollment: 431
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clopidogrel
75 mg clopidogrel once daily from Day 1 to Week 12
 Drug: clopidogrel (SR25990)
oral administration (tablets)
Active Comparator: Ticlopidine
200 mg ticlopidine once daily from Day 1 to Week 12
 Drug: ticlopidine
oral administration (tablets)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862420

Locations
Japan
Sanofi-Aventis Administrative Office
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Principal Investigator: Hiroshi Shigematsu, Head Professor/MD/PhD Second Department of Surgery (Vascular Surgery), Tokyo Medical University
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00862420     History of Changes
Other Study ID Numbers: SFY10810
Study First Received: March 9, 2009
Last Updated: July 16, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi:
Platelet aggregation inhibitors
Peripheral arterial disease (PAD)

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ticlopidine
Clopidogrel
Platelet Aggregation Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013