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Clinical Trials/NCT00593762
NCT00593762SuspendedNot Applicable

Investigation of Laboratory Resistance to Aspirin and Clopidogrel and Its Clinical Relevance in Patients With Peripheral Arterial Occlusive Disease Requiring Interventional Procedures

Johann Wolfgang Goethe University Hospital1 site in 1 country200 target enrollmentStarted: May 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Suspended
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Need for peripheral arterial revascularisation

Study Overview

Brief Summary

The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in patients with peripheral arterial occlusive disease (PAOD) requiring interventional procedures and to investigate if patients with "resistance" to ASA or Clopidogrel have an unfavourable outcome during long-term follow-up

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • PAOD patients
  • Age 18-85 years
  • Need for a catheter interventional procedure
  • Antithrombotic therapy with aspirin or clopidogrel

Exclusion Criteria

  • Comedication additionally compromising platelet function
  • Known bleeding disorder
  • Life expectancy < 6 months

Outcomes

Primary Outcomes

Need for peripheral arterial revascularisation

Time Frame: 1, 6, 12 and 24 months

Secondary Outcomes

  • Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI)(1, 6, 12 and 24 months)

Investigators

Sponsor
Johann Wolfgang Goethe University Hospital
Sponsor Class
Other

Study Sites (1)

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