Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
  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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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:


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) ]

Secondary Outcome Measures:
  • Bleeding adverse events, Serious adverse events, Overall safety [ Time Frame: Week 12, 52 (on treatment) ]
  • Vascular events [ Time Frame: Week 12, 52 (on study) ]
  • Safety events of interest (see above) [ Time Frame: Week 52 (on treatment) ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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

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
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 25, 2017