Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary Percutaneous Coronary Intervention or Coronary Artery Bypass Graft Population

Increased Drug Resistance Clinical Trial

— VASP  

Official title:

Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary PCI and CABG Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01408927
• Other study ID #: VASP
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2011
• Last updated: August 8, 2014
• Start date: October 2008
• Est. completion date: January 2016

Study information

• Verified date: August 2014
• Source: Medstar Research Institute
• Contact: Ron Waksman, MD
• Phone: 202-877-5975
• Email: ron.waksman[@]medstar.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The primary objective of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population undergoing contemporary percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG).

Description:

This is a prospective cohort study of 1000 patients presenting to the Washington Hospital Center for percutaneous coronary intervention or coronary artery bypass surgery.

The aim of this prospective clinical registry is to determine the prevalence and level of thienopyridine resistance seen in a population presenting for cardiac catheterization and undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Thienopyridine resistance will be measured by flow cytometry of the vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or the VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.

A secondary objective of this study is to correlate a variety of genetic polymorphisms with levels of platelet reactivity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient >18 years old.

2. PCI group only: Patient scheduled to undergo cardiac catheterization or underwent percutaneous coronary intervention (PCI), during hospital stay.

3. CABG group only: Patient is scheduled to undergo, or has underwent, coronary artery bypass surgery with at least one saphenous vein graft.

4. Treated with a loading dose of clopidogrel or prasugrel at least 6 hours prior to the blood draw, or on a maintenance dose of clopidogrel or prasugrel for a minimum of 5 days.

5. Genetic testing subgroup only: Patient has undergone PCI (only), and has been treated with a thienopyridine as in 4.

Exclusion Criteria:

1. Known allergies to aspirin, clopidogrel, or prasugrel;

2. Use of a glycoprotein (GP) IIb/IIIa within 8 hours of the blood draw;

3. Patient known to be pregnant or lactating;

4. Patient with known history of bleeding diathesis or currently active bleeding;

5. Platelet count <100,000/mm the day of the blood draw;

6. Hematocrit <25% the day of the blood draw;

7. On warfarin therapy at the time of the blood draw;

8. Known blood transfusion within the preceding 10 days of the blood draw;

9. Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;

10. Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Increased Drug Resistance

Intervention

Other:
• Thienopyridine resistance testing
Thienopyridine resistance will be measured by flow cytometry of vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.
• Aspirin resistance testing
Aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
• Genetic polymorphism assessment
The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence and degree of thienopyridine resistance	Thienopyridine resistance will be assessed by: oThe VASP assay, which measures the platelet reactivity index; and/or oThe VerifyNow P2Y12 receptor inhibition assay, which measures P2Y12 reaction units (PRU); and/or oThe Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation; and/or oThe PlaCor PRT 7000 platelet reactivity assay	Duration of hospital stay; average hospital stay of less than 48 hours	No
Secondary	The prevalence of aspirin resistance	The prevalence and degree of aspirin resistance will be measured by the VerifyNow aspirin resistance assay.	Duration of hospital stay; average hospital stay of less than 48 hours	No
Secondary	Correlate levels of platelet reactivity with the presence of selected genetic polymorphisms	The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.	Duration of hospital stay; average hospital stay of less than 48 hours	No