ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures

Suspended

• Conditions: Peripheral Arterial Occlusive Disease

• Registration Number: NCT00593762
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Status Verified: 2008-01
• Study First Submitted: 2008-01-03
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-15
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2010-03-15
• Last Update Posted: 2010-03-16

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Need for peripheral arterial revascularisation	1, 6, 12 and 24 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital; 🇩🇪 Frankfurt/Main, Hessen, Germany