NCT00593762

Brief Summary

The purpose of the study is to determine the response to aspirin (ASA) and Clopidogrel in patients with peripheral arterial occlusive disease (PAOD) requiring interventional procedures and to investigate if patients with "resistance" to ASA or Clopidogrel have an unfavourable outcome during long-term follow-up

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

May 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 16, 2010

Status Verified

January 1, 2008

Enrollment Period

4.6 years

First QC Date

January 3, 2008

Last Update Submit

March 15, 2010

Conditions

Peripheral Arterial Occlusive Disease

Keywords

Peripheral arterial occlusive diseaseAspirinClopidogrelResistanceCatheter interventional procedureASA and clopidogrel resistance

Outcome Measures

Primary Outcomes (1)

  • Need for peripheral arterial revascularisation

    1, 6, 12 and 24 months

Secondary Outcomes (1)

  • Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI)

    1, 6, 12 and 24 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with peripheral arterial occlusive disease (PAOD) requiring a catheter interventional procedure

You may qualify if:

  • PAOD patients
  • Age 18-85 years
  • Need for a catheter interventional procedure
  • Antithrombotic therapy with aspirin or clopidogrel

You may not qualify if:

  • Comedication additionally compromising platelet function
  • Known bleeding disorder
  • Life expectancy \< 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital

Frankfurt am Main, Hesse, D-60590, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

  • Birgit Linnemann, MD

    Division of Vascular Medicine, Department of Internal Medicine, J.W. Goethe University Hospital Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2008

First Posted

January 15, 2008

Study Start

May 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 16, 2010

Record last verified: 2008-01

Locations

DE(1)