NCT01183754
Completed
Not Applicable
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
CardioVascular Research Foundation, Korea1 site in 1 country3,000 target enrollmentMarch 2006
ConditionsCoronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- CardioVascular Research Foundation, Korea
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
Time Frame: at median 2 year after enrollment
Secondary Outcomes
- target-vessel revascularization(at median 2 year after enrollment)
- Composite of cardiovascular death, MI, stent thrombosis, or stroke(at median 2 year after enrollment)
- stent thrombosis(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)
Study Sites (1)
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