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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00163267
First received: September 8, 2005
Last updated: August 5, 2011
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    measured in a chandler loop model


Secondary Outcome Measures:
  • ABI [ Time Frame: before patients leaves the hospital and at 6 months ] [ Designated as safety issue: No ]
    as treatment effect

  • clinical improvement [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    dependent on the additional drug treatment

  • Safety [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
    dependent on the drug treatment with the endovascular treatment

  • rate of occlusions [ Time Frame: wihtin 6 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University Hospital Tuebingen

Additional 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
Study First Received: September 8, 2005
Last Updated: August 5, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014