Use of a Point-of-Care Platelet Function Assay for the Pr... | NCT01183754

Studies
Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events

NCT01183754

Sponsor

CardioVascular Research Foundation, Korea

Status

Completed

Last Update Posted

Feb 1, 2011Estimated

Enrollment

3,000Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

South Korea

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

Mar 2006

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

Mar 2006

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 17, 2010

First Submission Date that Met QC Criteria

Aug 17, 2010

First Posted Date

Aug 18, 2010Estimated

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

Jan 31, 2011

Last Update Posted Date

Feb 1, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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

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.

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

3,000Actual

Label	Type	Description	Intervention Names
patients receiving drug-eluting stents

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
death (all-cause and cardiovascular)		at median 2 year after enrollment
myocardial infarction		at median 2 year after enrollment
stent thrombosis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seung-Jung Park, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided