Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

263 patients with peripheral atherosclerosis were examined to evaluate the activity of the platelets during the standard treatment, including aspirin. A subgroup of 43 received 600 mg of clopidogrel 2 h before platelet reactivity analysis.

The main hypothesis is that high platelet activity at the beginning of the study is associated with a higher risk of atherothrombosis. Follow up time is 5 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aalborg Universitetshospital; Aalborg University Hospital
• Collaborator: Danish Heart Foundation
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

• Atherosclerosis of the lower limbs, defined by one of the following criteria:

Ankle-Brachial Pressure Index (ABPI)< 0.9, intermittent claudication, ischaemic pain at rest, ischaemic ulcers or gangrene.

• Age > 18 years

• For fertile women: Use of safe contraception (intrauterine contraceptive device, the pill, hormonal skin patches, progestogen injections, progestogen implant, vaginal ring)

Exclusion Criteria:

• Allergy to either Aspirin or Clopidogrel

• Known bleeding disorder

• Platelet count < 140 mia/L or > 400 mia/L

• Intake of NSAID's, SSRI's or Dipyridamol within the preceding 14 days

• Not radically treated gastrointestinal ulceration within the last 6 month

• Greater surgical procedures performed within the last 3 month

• Severe renal disease

• Severe hepatic disease

• Breast feeding

• Pregnancy