Mirror Trial - Follow-Up Management of Peripheral Arteria... | NCT00163267

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

NCT00163267

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Aug 9, 2011Estimated

Enrollment

80Actual

Phase

Phase 2Phase 3

Conditions

Peripheral Vascular Diseases

Interventions

clopidogrel

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
D.3100340

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Apr 2011Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2011

Last Update Posted Date

Aug 9, 2011Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASS + Placebo	Placebo Comparator	control arm	Drug: clopidogrel
ASS + Plavix	Active Comparator	active drug	Drug: clopidogrel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clopidogrel	Drug	Best endovascular treatment either with one or the other drug arm should be investigated	ASS + Placebo ASS + Plavix

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Platelet activation during and after the intervention	measured in a chandler loop model	6-12 hours

Secondary Outcomes

Measure	Description	Time Frame
ABI	as treatment effect	before patients leaves the hospital and at 6 months
clinical improvement	dependent on the additional drug treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gunnar Tepe, MD	University Hospital Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Tuebingen		Tübingen		72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24093324	Derived	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.

ID	Term
D016491	Peripheral Vascular Diseases
D050197	Atherosclerosis

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

ID	Term
D013988	Ticlopidine
D058924	Thienopyridines
D013876	Thiophenes
D013457	Sulfur Compounds