Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel
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ClinicalTrials.gov Identifier: NCT00163267 |
Recruitment Status
:
Completed
First Posted
: September 13, 2005
Last Update Posted
: August 9, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Vascular Diseases | Drug: clopidogrel | Phase 2 Phase 3 |
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 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 |

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

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

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
Germany | |
University Hospital of Tuebingen | |
Tuebingen, Germany, 72076 |
Principal Investigator: | Gunnar Tepe, MD | University Hospital Tuebingen |
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 Posted: | September 13, 2005 Key Record Dates |
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 |