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

University Hospital Tuebingen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Peripheral Vascular Diseases

Treatments: Drug: clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00163267

D.3100340

mi-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

ASS + Placebo

Placebo Comparator group

Description:

control arm

Treatment:

Drug: clopidogrel

ASS + Plavix

Active Comparator group

Description:

active drug

Treatment:

Drug: clopidogrel