NCT00163267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

August 9, 2011

Status Verified

April 1, 2007

Enrollment Period

4.3 years

First QC Date

September 8, 2005

Last Update Submit

August 5, 2011

Conditions

Peripheral Vascular Diseases

Keywords

peripheral arterial interventionatherosclerosisplateletsAge above 18

Outcome Measures

Primary Outcomes (1)

  • Platelet activation during and after the intervention

    measured in a chandler loop model

    6-12 hours

Secondary Outcomes (4)

  • ABI

    before patients leaves the hospital and at 6 months

  • clinical improvement

    up to 6 months

  • Safety

    up to 6 months

  • rate of occlusions

    wihtin 6 months

Study Arms (2)

ASS + Placebo

PLACEBO COMPARATOR

control arm

Drug: clopidogrel

ASS + Plavix

ACTIVE COMPARATOR

active drug

Drug: clopidogrel

Interventions

clopidogrelDRUG

Best endovascular treatment either with one or the other drug arm should be investigated

ASS + PlaceboASS + Plavix

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peripheral arterial disease which requires intervention

You may not qualify if:

  • Patient already on coumadin or clopidogrel
  • Acute onset of PVD symptoms
  • Patient requiring an operation
  • Contraindication to aspirin and clopidogrel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (1)

  • 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.

    PMID: 24093324DERIVED

MeSH Terms

Conditions

Peripheral Vascular DiseasesAtherosclerosis

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gunnar Tepe, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 13, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2009

Study Completion

April 1, 2011

Last Updated

August 9, 2011

Record last verified: 2007-04

Locations

DE(1)