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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Best endovascular treatment either with one or the other drug arm should be investigated
University Hospital of Tuebingen
Tübingen, Germany
Platelet activation during and after the intervention
measured in a chandler loop model
Time frame: 6-12 hours
ABI
as treatment effect
Time frame: before patients leaves the hospital and at 6 months
clinical improvement
dependent on the additional drug treatment
Time frame: up to 6 months
Safety
dependent on the drug treatment with the endovascular treatment
Time frame: up to 6 months
rate of occlusions
dependent on drug treatment
Time frame: wihtin 6 months
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