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

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ClinicalTrials.gov Identifier: NCT01183754
Recruitment Status : Completed
First Posted : August 18, 2010
Last Update Posted : February 1, 2011
Sponsor:
Information provided by:
CardioVascular Research Foundation, 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.

Condition or disease
Coronary Artery Disease

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.


Study Type : Observational
Actual Enrollment : 3000 participants
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
Study Start Date : March 2006
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Group/Cohort
patients receiving drug-eluting stents



Primary Outcome Measures :
  1. Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke [ Time Frame: at median 2 year after enrollment ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Blood sampling for genotyping (genetic subgroup analysis)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Clinical Research Center, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01183754     History of Changes
Other Study ID Numbers: 200603
First Posted: August 18, 2010    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: March 2006

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