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

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University Hospitals, January 2008

First Received: January 3, 2008 Last Updated: January 14, 2008 History of Changes

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00593762

Purpose

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

Condition
Peripheral Arterial Occlusive Disease

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Investigation of Laboratory Resistance to Aspirin and Clopidogrel and Its Clinical Relevance in Patients With Peripheral Arterial Occlusive Disease Requiring Interventional Procedures

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

Need for peripheral arterial revascularisation [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI) [ Time Frame: 1, 6, 12 and 24 months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood, serum

Estimated Enrollment:	200
Study Start Date:	May 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients with peripheral arterial occlusive disease (PAOD) requiring a catheter interventional procedure

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593762

Locations

Germany, Hessen
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital	Recruiting
Frankfurt/Main, Hessen, Germany, D-60590
Contact: Birgit Linnemann, MD +49 69 6301 5096 Birgit.Linnemann@kgu.de

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:

Birgit Linnemann, MD

Division of Vascular Medicine, Department of Internal Medicine, J.W. Goethe University Hospital Frankfurt

More Information

No publications provided

Responsible Party:	Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt ( PD Dr. E. Lindhoff-Last )
Study ID Numbers:	E 19/05
Study First Received:	January 3, 2008
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00593762 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:

Peripheral arterial occlusive disease
Aspirin
Clopidogrel

Resistance
Catheter interventional procedure
ASA and clopidogrel resistance

Study placed in the following topic categories:

Arterial Occlusive Diseases
Aspirin
Clopidogrel
Vascular Diseases
Platelet Aggregation Inhibitors

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Therapeutic Uses
Clopidogrel
Hematologic Agents

Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009