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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01183754

Acronym

ASAN-VERIFY

Enrollment

3000

Registered

2010-08-18

Start date

2006-03-31

Completion date

2010-12-31

Last updated

2011-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

platelet reactivity, drug-eluting stent, coronary disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
target-vessel revascularization	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
stent thrombosis	at median 2 year after enrollment

Countries

South Korea

Outcome results