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

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:

MedlinePlus related topics: Vascular Diseases

Drug Information available for: Clopidogrel bisulfate

U.S. FDA Resources

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 (Adult, Senior)
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

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
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 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

ClinicalTrials.gov processed this record on September 28, 2016