Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
- Registration Number
- NCT00163267
- Lead Sponsor
- University Hospital Tuebingen
- Brief Summary
The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.
- Detailed Description
Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact.
Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Peripheral arterial disease which requires intervention
- Patient already on coumadin or clopidogrel
- Acute onset of PVD symptoms
- Patient requiring an operation
- Contraindication to aspirin and clopidogrel
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASS + Placebo clopidogrel control arm ASS + Plavix clopidogrel active drug
- Primary Outcome Measures
Name Time Method Platelet activation during and after the intervention 6-12 hours measured in a chandler loop model
- Secondary Outcome Measures
Name Time Method ABI before patients leaves the hospital and at 6 months as treatment effect
clinical improvement up to 6 months dependent on the additional drug treatment
Safety up to 6 months dependent on the drug treatment with the endovascular treatment
rate of occlusions wihtin 6 months dependent on drug treatment
Trial Locations
- Locations (1)
University Hospital of Tuebingen
🇩🇪Tuebingen, Germany