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

Peripheral Arterial Occlusive Disease Clinical Trial

Official title:

Investigation of Laboratory Resistance to Aspirin and Clopidogrel and Its Clinical Relevance in Patients With Peripheral Arterial Occlusive Disease Requiring Interventional Procedures

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00593762
• Other study ID #: E 19/05
• Status: Suspended
• Phase: N/A
• First received: January 3, 2008
• Last updated: March 15, 2010
• Start date: May 2005
• Est. completion date: December 2009

Study information

• Verified date: January 2008
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Locations

Country	Name	City	State
Germany	Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital	Frankfurt/Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for peripheral arterial revascularisation		1, 6, 12 and 24 months	No
Secondary	Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI)		1, 6, 12 and 24 months	No