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
Study Sites (1)
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