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

This study is currently recruiting participants.

Verified by University Hospital Tuebingen, April 2007

First Received: September 8, 2005 Last Updated: April 18, 2007 History of Changes

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00163267

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 II Phase III

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Platelet activation during and after the intervention

Secondary Outcome Measures:

ABI
clinical improvement
Safety
rate of occlusions
microcirculation

Estimated Enrollment:	80
Study Start Date:	September 2005
Estimated Study Completion Date:	October 2008

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163267

Contacts

Contact: Gunnar Tepe, MD	004970712986677	gunnar.tepe@med.uni-tuebingen.de
Contact: Kerstin Klipp		kerstin.klipp@med.uni-tuebingen.de

Locations

Germany
University Hospital of Tuebingen	Recruiting
Tuebingen, Germany, 72076
Contact: Gunnar Tepe, MD 4970712986677 gunnar.tepe@med.uni-tuebingen.de
Principal Investigator: Gunnar Tepe, MD

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Gunnar Tepe, MD

University Hospital Tuebingen

More Information

No publications provided

Study ID Numbers:	mi-1, D.3100340
Study First Received:	September 8, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00163267 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

peripheral arterial intervention
atherosclerosis
platelets
Age above 18

Study placed in the following topic categories:

Atherosclerosis
Peripheral Vascular Diseases
Clopidogrel
Vascular Diseases
Platelet Aggregation Inhibitors

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Therapeutic Uses
Clopidogrel
Hematologic Agents

Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009