Coronary Artery DiseaseASAN-VERIFYNCT01183754
Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events
An observational study of Coronary Artery Disease, run by CardioVascular Research Foundation, Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Consecutive patients with established coronary artery disease receiving PCI with stent implantation
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary disease, platelet reactivity, drug-eluting stent
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients receiving drug-eluting stents | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
Measured: at median 2 year after enrollment
Secondary outcomes (7)
death (all-cause and cardiovascular)
Measured: at median 2 year after enrollment
myocardial infarction
Measured: at median 2 year after enrollment
stent thrombosis
Measured: at median 2 year after enrollment
stroke
Measured: at median 2 year after enrollment
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Measured: at median 2 year after enrollment
target-vessel revascularization
Measured: at median 2 year after enrollment
Composite of cardiovascular death, MI, stent thrombosis, or stroke
Measured: at median 2 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startMar 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardioVascular Research Foundation, Korea
- Sponsor type
- University, hospital or other
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183754
- Sponsor's protocol ID
- 200603
- Acronym
- ASAN-VERIFY
- Status last verified
- Mar 2006
- First submitted
- 17 Aug 2010
- Last updated
- 1 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01183754
- Acronym / sponsor ID
- ASAN-VERIFY / 200603
- Conditions
- Coronary Artery Disease
- Keywords
- coronary disease, platelet reactivity, drug-eluting stent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- CardioVascular Research Foundation, KoreaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients receiving drug-eluting stents | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Consecutive patients with established coronary artery disease receiving PCI with stent implantation
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke
Time frame: at median 2 year after enrollment
7 secondary outcomes
death (all-cause and cardiovascular)
Time frame: at median 2 year after enrollment
myocardial infarction
Time frame: at median 2 year after enrollment
stent thrombosis
Time frame: at median 2 year after enrollment
stroke
Time frame: at median 2 year after enrollment
Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding
Time frame: at median 2 year after enrollment
target-vessel revascularization
Time frame: at median 2 year after enrollment
Composite of cardiovascular death, MI, stent thrombosis, or stroke
Time frame: at median 2 year after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Jung Park, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by CardioVascular Research Foundation, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke (time frame: at median 2 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2011.