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Aspirin in peripheral arterial disease: breakthrough or pitfall?
E Singer1, S Imfeld, U Hoffmann
1Department of Angiology, University of Basel Medical School, Petersgraben 4, CH-4031 Basel, Switzerland. singer_angioresearch_kbs@ftml.net
VASA. Zeitschrift Fur Gefasskrankheiten
|August 31, 2006
Summary
This study investigates if Aspirin (ASA) or Clopidogrel is better for peripheral arterial disease (PAD) patients undergoing rehabilitation. Animal studies suggest ASA may hinder collateral network formation, a finding this trial aims to confirm in humans.
Area of Science:
- Vascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Peripheral arterial disease (PAD) management often involves anti-platelet therapy.
- Previous animal models indicate Aspirin (ASA) may inhibit arteriogenesis, unlike Clopidogrel.
- This study aims to validate these findings in human subjects.
Purpose of the Study:
- To compare the efficacy of Aspirin (ASA) versus Clopidogrel in PAD patients undergoing rehabilitation.
- To determine if ASA inhibits arteriogenesis in humans, as suggested by animal studies.
- To inform potential changes in standard anti-platelet treatment protocols for PAD.
Main Methods:
- A prospective, double-blind, multicenter trial randomizing 250 PAD patients to ASA or Clopidogrel.
- A three-month rehabilitation program with daily physical training to stimulate arteriogenesis.
- Claudication distance and 24-hour physical activity profiles assessed at baseline and follow-up.
Main Results:
- Primary endpoint: Claudication distances at baseline, 6 weeks, and 3 months.
- Secondary endpoint: 24-hour physical activity profiles.
- Analysis will focus on differences in rehabilitation outcomes between ASA and Clopidogrel groups.
Conclusions:
- The trial will provide crucial data on the potential adverse effects of ASA in PAD patients.
- If animal findings are replicated, current anti-platelet treatment standards for PAD may require re-evaluation.
- Results could significantly impact clinical practice for PAD management.
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