Safety Evaluation of Clopidogrel Sulfate in Patients With Peripheral Arterial Disease

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00862420

Enrollment

431

Registered

2009-03-16

Start date

2009-02-28

Completion date

2011-05-31

Last updated

2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease (PAD)

Keywords

Platelet aggregation inhibitors, Peripheral arterial disease (PAD)

Brief 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

Interventions

DRUGclopidogrel (SR25990)

oral administration (tablets)

DRUGticlopidine

oral administration (tablets)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Safety events of interest including clinical significant bleeding, blood disorders, hepatic dysfunction and other serious adverse drug reactions (death, hospitalization...)	Week 12 (on treatment)

Secondary

Measure	Time frame
Bleeding adverse events, Serious adverse events, Overall safety	Week 12, 52 (on treatment)
Vascular events	Week 12, 52 (on study)
Safety events of interest (see above)	Week 52 (on treatment)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026