Back to resultsMirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
Primary Purpose
Peripheral Vascular Diseases
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring peripheral arterial intervention, atherosclerosis, platelets, Age above 18
Eligibility 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
Sites / Locations
- University Hospital of Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
ASS + Placebo
ASS + Plavix
Arm Description
control arm
active drug
Outcomes
Primary Outcome Measures
Platelet activation during and after the intervention
measured in a chandler loop model
Secondary Outcome Measures
ABI
as treatment effect
clinical improvement
dependent on the additional drug treatment
Safety
dependent on the drug treatment with the endovascular treatment
rate of occlusions
dependent on drug treatment
Full Information
NCT ID
NCT00163267
First Posted
September 8, 2005
Last Updated
August 5, 2011
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00163267
Brief Title
Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
Official Title
Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases
Keywords
peripheral arterial intervention, atherosclerosis, platelets, Age above 18
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASS + Placebo
Arm Type
Placebo Comparator
Arm Description
control arm
Arm Title
ASS + Plavix
Arm Type
Active Comparator
Arm Description
active drug
Intervention Type
Drug
Intervention Name(s)
clopidogrel
Intervention Description
Best endovascular treatment either with one or the other drug arm should be investigated
Primary Outcome Measure Information:
Title
Platelet activation during and after the intervention
Description
measured in a chandler loop model
Time Frame
6-12 hours
Secondary Outcome Measure Information:
Title
ABI
Description
as treatment effect
Time Frame
before patients leaves the hospital and at 6 months
Title
clinical improvement
Description
dependent on the additional drug treatment
Time Frame
up to 6 months
Title
Safety
Description
dependent on the drug treatment with the endovascular treatment
Time Frame
up to 6 months
Title
rate of occlusions
Description
dependent on drug treatment
Time Frame
wihtin 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Tepe, MD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
24093324
Citation
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.
Results Reference
derived
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Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
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