Status:
COMPLETED
Resistance to Aspirin and/or Clopidogrel Among Patients With PAD.
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Danish Heart Foundation
Conditions:
Intermittent Claudication
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
Patients with peripheral atherosclerosis are at high risk of atherothrombosis, mainly heart attack and stroke. The medical treatment of these patients include platelet inhibiting drugs, usually aspiri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT00262561
Start Date
January 1 2006
End Date
January 1 2008
Last Update
January 28 2014
Active Locations (1)
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1
Department of Vascular Surgery, Aalborg Hospital
Aalborg, Denmark, 9000