ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures
March 15, 2010 updated by: Johann Wolfgang Goethe University Hospital
Investigation of Laboratory Resistance to Aspirin and Clopidogrel and Its Clinical Relevance in Patients With Peripheral Arterial Occlusive Disease Requiring Interventional Procedures
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 Overview
Status
Suspended
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hessen
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Frankfurt/Main, Hessen, Germany, D-60590
- Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with peripheral arterial occlusive disease (PAOD) requiring a catheter interventional procedure
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Need for peripheral arterial revascularisation
Time Frame: 1, 6, 12 and 24 months
|
1, 6, 12 and 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI)
Time Frame: 1, 6, 12 and 24 months
|
1, 6, 12 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Birgit Linnemann, MD, Division of Vascular Medicine, Department of Internal Medicine, J.W. Goethe University Hospital Frankfurt
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Anticipated)
December 1, 2009
Study Completion (Anticipated)
December 1, 2009
Study Registration Dates
First Submitted
January 3, 2008
First Submitted That Met QC Criteria
January 14, 2008
First Posted (Estimate)
January 15, 2008
Study Record Updates
Last Update Posted (Estimate)
March 16, 2010
Last Update Submitted That Met QC Criteria
March 15, 2010
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E 19/05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.