NCT00862420

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

2.2 years

First QC Date

March 9, 2009

Last Update Submit

July 16, 2012

Conditions

Peripheral Arterial Disease (PAD)

Keywords

Platelet aggregation inhibitorsPeripheral arterial disease (PAD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

Study Arms (2)

Clopidogrel

EXPERIMENTAL

75 mg clopidogrel once daily from Day 1 to Week 12

Drug: clopidogrel (SR25990)

Ticlopidine

ACTIVE COMPARATOR

200 mg ticlopidine once daily from Day 1 to Week 12

Drug: ticlopidine

Interventions

clopidogrel (SR25990)DRUG

oral administration (tablets)

Clopidogrel
ticlopidineDRUG

oral administration (tablets)

Ticlopidine

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis Administrative Office

Tokyo, Japan

Location

Related Publications (1)

  • Shigematsu H, Komori K, Tanemoto K, Harada Y, Nakamura M. Clopidogrel for Atherothrombotic Event Management in Patients with Peripheral Arterial Disease (COOPER) Study: Safety and Efficacy of Clopidogrel versus Ticlopidine in Japanese Patients. Ann Vasc Dis. 2012;5(3):364-75. doi: 10.3400/avd.oa.12.00039.

    PMID: 23555538DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

ClopidogrelTiclopidine

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

ThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Hiroshi Shigematsu, Head Professor/MD/PhD

    Second Department of Surgery (Vascular Surgery), Tokyo Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2009

First Posted

March 16, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

JP(1)