Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

Peripheral Arterial Disease (PAD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00862420
• Other study ID #: SFY10810
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2009
• Last updated: July 16, 2012
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Disease (PAD)
• Peripheral Vascular Diseases

Intervention

Drug:
• clopidogrel (SR25990)
oral administration (tablets)
• ticlopidine
oral administration (tablets)

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)		Week 12 (on treatment)	Yes
Secondary	Bleeding adverse events, Serious adverse events, Overall safety		Week 12, 52 (on treatment)	Yes
Secondary	Vascular events		Week 12, 52 (on study)	No
Secondary	Safety events of interest (see above)		Week 52 (on treatment)	Yes