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

NCT01183754 | Completed DMC

• 1 other identifier: 200603
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the role of VerifyNow test as prognostic marker in routine clinical practice using drug-eluting stents.
2. 2.To determine the add-on-effect of VerifyNow test beyond on conventional risk factors (clinical, lesions, or procedural factors).
3. 3.To compare the prognostic utility of VerifyNow test with several biomarkers.

Conditions

Coronary Artery Disease

Keywords

coronary disease; platelet reactivity; drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke

  at median 2 year after enrollment

Secondary Outcomes (7)

• death (all-cause and cardiovascular)

  at median 2 year after enrollment

• myocardial infarction

  at median 2 year after enrollment

• stent thrombosis

  at median 2 year after enrollment

• stroke

  at median 2 year after enrollment

• Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding

  at median 2 year after enrollment

Study Arms (1)

patients receiving drug-eluting stents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Consecutive patients with established coronary artery disease receiving PCI with stent implantation

You may not qualify if:

• 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.

Sponsors & Collaborators

• CardioVascular Research Foundation, Korea: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sampling for genotyping (genetic subgroup analysis)

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Seung-Jung Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 18, 2010
• Study Start: March 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 1, 2011

Record last verified: 2006-03

Locations

KR (1)