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

Coronary Artery Disease Clinical Trial

— ASAN-VERIFY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183754
• Other study ID #: 200603
• Status: Completed
• Phase: N/A
• First received: August 17, 2010
• Last updated: January 31, 2011
• Start date: March 2006
• Est. completion date: December 2010

Study information

• Verified date: March 2006
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical 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. To compare the prognostic utility of VerifyNow test with several biomarkers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke		at median 2 year after enrollment	Yes
Secondary	death (all-cause and cardiovascular)		at median 2 year after enrollment	Yes
Secondary	myocardial infarction		at median 2 year after enrollment	Yes
Secondary	stent thrombosis		at median 2 year after enrollment	Yes
Secondary	stroke		at median 2 year after enrollment	Yes
Secondary	Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding		at median 2 year after enrollment	Yes
Secondary	target-vessel revascularization		at median 2 year after enrollment	Yes
Secondary	Composite of cardiovascular death, MI, stent thrombosis, or stroke		at median 2 year after enrollment	Yes