NCT00862420

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

Completed Phase 3 Last updated 16 July 2012

What this trial tests

Phase 3 trial testing clopidogrel (SR25990) in Peripheral Arterial Disease (PAD) in 431 participants. Completed in 1 May 2011.

Timeline

1 February 2009

Primary endpoint
1 May 2011

1 May 2011

Quick facts

Lead sponsor	Sanofi
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	431
Start date	1 February 2009
Primary completion	1 May 2011
Estimated completion	1 May 2011
Sites	1 location across Japan

Drugs / interventions tested

• clopidogrel (SR25990) — full drug profile →
• ticlopidine (TICLOPIDINE) — full drug profile →

Conditions studied

• Peripheral Arterial Disease (PAD) — all drugs for Peripheral Arterial Disease (PAD) →

Sponsor

Sanofi — full company profile →

Who can join

20 and older, any sex, with Peripheral Arterial Disease (PAD). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy and Safety of Antiplatelet Therapies in Symptomatic Peripheral Artery Disease: A Systematic Review and Network Meta-Analysis.
   De Carlo M, Di Minno G, Sayre T, Fazeli MS, et al · · 2021 · cited 16× · PMID 32819249 · DOI 10.2174/1570161118666200820141131
2. Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients.
   Shigematsu H, Komori K, Tanemoto K, Harada Y, et al · · 2012 · cited 10× · PMID 23555538 · DOI 10.3400/avd.oa.12.00039