Clinical trial NCT01183754: Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary disease
platelet reactivity
drug-eluting stent
Lead sponsor: CardioVascular Research Foundation, Korea
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Primary outcomes:
measure: Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
timeFrame: at median 2 year after enrollment
Secondary outcomes:
measure: death (all-cause and cardiovascular)
timeFrame: at median 2 year after enrollment
measure: myocardial infarction
timeFrame: at median 2 year after enrollment
measure: stent thrombosis
timeFrame: at median 2 year after enrollment
measure: stroke
timeFrame: at median 2 year after enrollment
measure: Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
timeFrame: at median 2 year after enrollment
measure: target-vessel revascularization
timeFrame: at median 2 year after enrollment
measure: Composite of cardiovascular death, MI, stent thrombosis, or stroke
timeFrame: at median 2 year after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Seung-Jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: