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

Peripheral Vascular Diseases Clinical Trial

Official title:

Follow-up Management of Peripheral Arterial Intervention With Clopidogrel MIRROR-Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163267
• Other study ID #: mi-1
• Secondary ID: D.3100340
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: August 5, 2011
• Start date: September 2005
• Est. completion date: April 2011

Study information

• Verified date: April 2007
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• clopidogrel
Best endovascular treatment either with one or the other drug arm should be investigated

Locations

Country	Name	City	State
Germany	University Hospital of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet activation during and after the intervention	measured in a chandler loop model	6-12 hours	No
Secondary	ABI	as treatment effect	before patients leaves the hospital and at 6 months	No
Secondary	clinical improvement	dependent on the additional drug treatment	up to 6 months	Yes
Secondary	Safety	dependent on the drug treatment with the endovascular treatment	up to 6 months	Yes
Secondary	rate of occlusions	dependent on drug treatment	wihtin 6 months	Yes