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Completed

NCT Number: NCT00163267

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

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.

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Key information

Conditions

Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital of Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel

Drug

Best endovascular treatment either with one or the other drug arm should be investigated

Primary outcomes

  1. Platelet activation during and after the intervention

    Time frame: 6-12 hours

    measured in a chandler loop model

Secondary outcomes

  1. ABI

    Time frame: before patients leaves the hospital and at 6 months

    as treatment effect

  2. clinical improvement

    Time frame: up to 6 months

    dependent on the additional drug treatment

  3. Safety

    Time frame: up to 6 months

    dependent on the drug treatment with the endovascular treatment

  4. rate of occlusions

    Time frame: wihtin 6 months

    dependent on drug treatment

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Sep 13, 2005
Registry last updated
Aug 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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