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

This study has suspended participant recruitment.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier:
NCT00593762
First received: January 3, 2008
Last updated: March 15, 2010
Last verified: January 2008
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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

Resource links provided by NLM:


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

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
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital
Frankfurt/Main, Hessen, Germany, D-60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Birgit Linnemann, MD Division of Vascular Medicine, Department of Internal Medicine, J.W. Goethe University Hospital Frankfurt
  More Information

Responsible Party: PD Dr. E. Lindhoff-Last, Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital Frankfurt
ClinicalTrials.gov Identifier: NCT00593762     History of Changes
Other Study ID Numbers: E 19/05 
Study First Received: January 3, 2008
Last Updated: March 15, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospital:
Peripheral arterial occlusive disease
Aspirin
Clopidogrel
Resistance
Catheter interventional procedure
ASA and clopidogrel resistance

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 25, 2016