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

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT01183754
• Lead Sponsor: CardioVascular Research Foundation, Korea

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.

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 Timeline

• Status Verified: 2006-03
• Study Start: 2006-03
• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-17
• Study First Posted: 2010-08-18
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-01-31
• Last Update Posted: 2011-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
stent thrombosis	at median 2 year after enrollment
target-vessel revascularization	at median 2 year after enrollment
Composite of cardiovascular death, MI, stent thrombosis, or stroke	at median 2 year after enrollment
death (all-cause and cardiovascular)	at median 2 year after enrollment
myocardial infarction	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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of