Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel

Study Overview
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Brief Summary
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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
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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.

Official Title
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Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Drug: clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peripheral arterial disease which requires intervention Exclusion Criteria: Patient already on coumadin or clopidogrel Acute onset of PVD symptoms Patient requiring an operation Contraindication to aspirin and clopidogrel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: ASS + Placebo<br>control arm | Drug: clopidogrel<br>* Best endovascular treatment either with one or the other drug arm should be investigated<br>|
| Active Comparator: ASS + Plavix<br>active drug | Drug: clopidogrel<br>* Best endovascular treatment either with one or the other drug arm should be investigated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet activation during and after the intervention | measured in a chandler loop model | 6-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABI | as treatment effect | before patients leaves the hospital and at 6 months | 
| clinical improvement | dependent on the additional drug treatment | up to 6 months | 
| Safety | dependent on the drug treatment with the endovascular treatment | up to 6 months | 
| rate of occlusions | dependent on drug treatment | wihtin 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral arterial intervention, atherosclerosis, platelets, Age above 18