ASA- and Clopidogrel-Responsiveness in Patients With Peri... | NCT00593762

Studies
ASA- and Clopidogrel-Responsiveness in Patients With Peripheral Arterial Occlusive Disease and Interventional Procedures

NCT00593762

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Suspended

Last Update Posted

Mar 16, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Peripheral Arterial Occlusive Disease

Interventions

Not provided

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

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Jan 3, 2008

First Submission Date that Met QC Criteria

Jan 14, 2008

First Posted Date

Jan 15, 2008Estimated

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

Mar 15, 2010

Last Update Posted Date

Mar 16, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Need for peripheral arterial revascularisation		1, 6, 12 and 24 months

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular events (death, myocardial infarction, stroke, ACS, PCI)		1, 6, 12 and 24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Birgit Linnemann, MD	Division of Vascular Medicine, Department of Internal Medicine, J.W. Goethe University Hospital Frankfurt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Vascular Medicine, Department of Internal Medicine, J.W.Goethe University Hospital		Frankfurt am Main	Hesse	D-60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
C564658	Peripheral Arterial Occlusive Disease 1

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided