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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Vascular Diseases	Drug: clopidogrel	Phase 2; Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study
Study Start Date :	September 2005
Actual Primary Completion Date :	December 2009
Actual Study Completion Date :	April 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: ASS + Placebo; control arm	Drug: clopidogrel; Best endovascular treatment either with one or the other drug arm should be investigated
Active Comparator: ASS + Plavix; active drug	Drug: clopidogrel; Best endovascular treatment either with one or the other drug arm should be investigated

Outcome Measures

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Primary Outcome Measures :

1. Platelet activation during and after the intervention [ Time Frame: 6-12 hours ]
   measured in a chandler loop model

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Germany
University Hospital of Tuebingen
Tuebingen, Germany, 72076

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:	Gunnar Tepe, MD	University Hospital Tuebingen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Strobl FF, Brechtel K, Schmehl J, Zeller T, Reiser MF, Claussen CD, Tepe G. Twelve-month results of a randomized trial comparing mono with dual antiplatelet therapy in endovascularly treated patients with peripheral artery disease. J Endovasc Ther. 2013 Oct;20(5):699-706. doi: 10.1583/13-4275MR.1.

Responsible Party:	Mirror Trial, University of Tuebingen
ClinicalTrials.gov Identifier:	NCT00163267 History of Changes
Other Study ID Numbers:	mi-1; D.3100340
First Posted:	September 13, 2005
Last Update Posted:	August 9, 2011
Last Verified:	April 2007

Keywords provided by University Hospital Tuebingen:

peripheral arterial intervention; atherosclerosis; platelets; Age above 18

Additional relevant MeSH terms:

Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Clopidogrel; Ticlopidine; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists	Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Fibrinolytic Agents; Fibrin Modulating Agents; Cytochrome P-450 CYP2C19 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors