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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163267
First Posted: September 13, 2005
Last Update Posted: August 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Tuebingen
  Purpose
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 Intervention Phase
Peripheral Vascular Diseases Drug: clopidogrel Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Platelet activation during and after the intervention [ Time Frame: 6-12 hours ]
    measured in a chandler loop model


Secondary Outcome Measures:
  • ABI [ Time Frame: before patients leaves the hospital and at 6 months ]
    as treatment effect

  • clinical improvement [ Time Frame: up to 6 months ]
    dependent on the additional drug treatment

  • Safety [ Time Frame: up to 6 months ]
    dependent on the drug treatment with the endovascular treatment

  • rate of occlusions [ Time Frame: wihtin 6 months ]
    dependent on drug treatment


Enrollment: 80
Study Start Date: September 2005
Study Completion Date: April 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163267


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mirror Trial, University of Tuebingen
ClinicalTrials.gov Identifier: NCT00163267     History of Changes
Other Study ID Numbers: mi-1
D.3100340
First Submitted: September 8, 2005
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