- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01183754
Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events (ASAN-VERIFY)
January 31, 2011 updated by: CardioVascular Research Foundation, Korea
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
- 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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Asan Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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)
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
patients receiving drug-eluting stents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
death (all-cause and cardiovascular)
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
myocardial infarction
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
stent thrombosis
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
stroke
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
target-vessel revascularization
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
Composite of cardiovascular death, MI, stent thrombosis, or stroke
Time Frame: at median 2 year after enrollment
|
at median 2 year after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
August 17, 2010
First Submitted That Met QC Criteria
August 17, 2010
First Posted (Estimate)
August 18, 2010
Study Record Updates
Last Update Posted (Estimate)
February 1, 2011
Last Update Submitted That Met QC Criteria
January 31, 2011
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200603 (OTHER_GRANT: OMAFRA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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