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

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

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00593762

Enrollment

200

Registered

2008-01-15

Start date

2005-05-31

Completion date

2009-12-31

Last updated

2010-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Peripheral arterial occlusive disease, Aspirin, Clopidogrel, Resistance, Catheter interventional procedure, ASA and clopidogrel resistance

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Need for peripheral arterial revascularisation	1, 6, 12 and 24 months

Secondary

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

Countries

Germany

Outcome results