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OpenTrials
Completed

NCT Number: NCT01183754

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke

    Time frame: at median 2 year after enrollment

Secondary outcomes

  1. death (all-cause and cardiovascular)

    Time frame: at median 2 year after enrollment

  2. myocardial infarction

    Time frame: at median 2 year after enrollment

  3. stent thrombosis

    Time frame: at median 2 year after enrollment

  4. stroke

    Time frame: at median 2 year after enrollment

  5. Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding

    Time frame: at median 2 year after enrollment

  6. target-vessel revascularization

    Time frame: at median 2 year after enrollment

  7. Composite of cardiovascular death, MI, stent thrombosis, or stroke

    Time frame: at median 2 year after enrollment

Sponsors and collaborators

Lead sponsor

CardioVascular Research Foundation, Korea

Other

Registry information

Official study 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

Acronym: ASAN-VERIFY

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 18, 2010
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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