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Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events (ASAN-VERIFY)

This study has been completed.
Sponsor:
Information provided by:
CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01183754
First received: August 17, 2010
Last updated: January 31, 2011
Last verified: March 2006
History of Changes
  Purpose
  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.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • death (all-cause and cardiovascular) [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]
  • myocardial infarction [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]
  • Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]
  • target-vessel revascularization [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]
  • Composite of cardiovascular death, MI, stent thrombosis, or stroke [ Time Frame: at median 2 year after enrollment ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood sampling for genotyping (genetic subgroup analysis)


Enrollment: 3000
Study Start Date: March 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients receiving drug-eluting stents

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183754

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Asan Medical Center
  More Information

No publications provided

Responsible Party: Clinical Research Center, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01183754     History of Changes
Other Study ID Numbers: 200603
Study First Received: August 17, 2010
Last Updated: January 31, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
coronary disease
platelet reactivity
drug-eluting stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013