Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00862420

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Ticlopidine hydrochloride Ticlopidine Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	400
Study Start Date:	February 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 75 mg clopidogrel once daily from Day 1 to Week 12	Drug: clopidogrel (SR25990) oral administration (tablets)
2: Active Comparator 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

Contacts

Contact: Public Registry ICD

GV-contact-us@sanofi-aventis.com

Locations

Japan
Sanofi-aventis Administrative Office	Recruiting
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

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-aventis ( ICD Study Director )
Study ID Numbers:	SFY10810
Study First Received:	March 9, 2009
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00862420 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency; Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

Platelet aggregation inhibitors
Peripheral arterial disease (PAD)

Study placed in the following topic categories:

Fibrin Modulating Agents
Ticlopidine
Peripheral Vascular Diseases
Clopidogrel

Vascular Diseases
Fibrinolytic Agents
Platelet Aggregation Inhibitors
Cardiovascular Agents

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Ticlopidine
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents

Pharmacologic Actions
Fibrin Modulating Agents
Clopidogrel
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 11, 2009