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Clinical Trials/NCT01183754
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

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

  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.

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
December 2010
Last Updated
15 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CardioVascular Research Foundation, Korea

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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