NCT01183754

Completed

Use of a Point-of-Care Platelet Function Assay for the Predi...

CardioVascular Research Foundation, Korea Source

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Other study identifiers

Sponsor study identifier

200603

Study Type

observational

Actual enrollment (reported)

3,000

Locations

1 country

Sites

1

Timeline

Study Start

March 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2010

Actual (reported)

Study Completion

December 2010

Actual (reported)

Brief Summary

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 3,000 participants
Study completion date: December 2010
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
March 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 17, 2010
Actual (reported)
First Posted
August 18, 2010
Actual (reported)
Primary Completion
December 2010
Actual (reported)
Study Completion
December 2010
Actual (reported)

Last Updated: February 1, 2011
Status Verified: March 2006
Last Update Submitted: January 31, 2011

Conditions

Coronary Artery Disease

Keywords

coronary diseaseplatelet reactivitydrug-eluting stent

Outcome Measures

Primary Outcomes (1)

Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
at median 2 year after enrollment

Secondary Outcomes (7)

death (all-cause and cardiovascular)
at median 2 year after enrollment
myocardial infarction
at median 2 year after enrollment
stent thrombosis
at median 2 year after enrollment
stroke
at median 2 year after enrollment
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
at median 2 year after enrollment
+2 more secondary outcomes

Study Arms (1)

patients receiving drug-eluting stents

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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)

You may qualify if:

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

Sponsors & Collaborators

CardioVascular Research Foundation, Korea
Otherlead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling for genotyping (genetic subgroup analysis)

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

Seung-Jung Park, MD, PhD
Asan Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

3,000 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 18, 2010

Study Start

March 2006

Date type not reported

This date has not been verified as actual or estimated.

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Phase 3Completed

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Phase 4Completed

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You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

December 2010

Actual (reported)

Study Completion

December 2010

Actual (reported)

Last Updated

February 1, 2011

Record last verified: 2006-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01183754
Data provider: ClinicalTrials.gov
Source updated: 2011-02-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:48 UTC

Locations

KR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

patients receiving drug-eluting stents

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations