Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events (ASAN-VERIFY)

January 31, 2011 updated by: CardioVascular Research Foundation, Korea

Use of a Point-of-Care Platelet Function Assay to Improve the Prediction of Atherothrombotic Events After Implantation of Drug-Eluting Stents: ASAN-VerifyNow Registry

  1. To evaluate the role of VerifyNow test as prognostic marker in routine clinical practice using drug-eluting stents.
  2. To determine the add-on-effect of VerifyNow test beyond on conventional risk factors (clinical, lesions, or procedural factors).
  3. To compare the prognostic utility of VerifyNow test with several biomarkers.

Study Overview

Status

Completed

Conditions

Detailed Description

Predictive role of a point-of-care assay (VerifyNow test) has not been well evaluated in large number of patients receiving drug-eluting stents as a routine practice.

In addition, additional predictive effect of a point-of-care assay, as compared to conventional clinical factors or other biomarkers, might be clinically interesting and important.

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population included consecutive patients with de novo coronary artery disease who underwent an initial PCI with drug-eluting stents and had VerifyNow test at the Asan Medical Center (Seoul, Korea)

Description

Inclusion Criteria:

  • Consecutive patients with established coronary artery disease receiving PCI with stent implantation

Exclusion Criteria:

  • Cardiogenic shock
  • Patients using concomitant medication known to affect platelet function other than aspirin (i.e. nonsteroidal antiinflammatory agents, dipyramidole, upstream glycoprotein IIb/IIIa inhibitors)
  • patients with a known platelet function disorder or a whole blood platelet count of less than 150000/μL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
patients receiving drug-eluting stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
death (all-cause and cardiovascular)
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment
myocardial infarction
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment
stent thrombosis
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment
stroke
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment
target-vessel revascularization
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment
Composite of cardiovascular death, MI, stent thrombosis, or stroke
Time Frame: at median 2 year after enrollment
at median 2 year after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CardioVascular Research Foundation, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 17, 2010

First Posted (Estimate)

August 18, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2011

Last Update Submitted That Met QC Criteria

January 31, 2011

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200603 (OTHER_GRANT: OMAFRA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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