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

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

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).

Study Overview

• Status: Unknown
• Conditions: Increased Drug Resistance
• Intervention / Treatment: Other: Thienopyridine resistance testing; Other: Aspirin resistance testing; Other: Genetic polymorphism assessment

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Recruiting
      • Washington Hospital Center
      • Contact: Ron Waksman, MD; Phone Number: 202-877-5975; Email: ron.waksman@medstar.net

Participation Criteria

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

1000 patients, male or female, older than 18 years of age, who are scheduled for or underwent percutaneous coronary intervention (PCI) or CABG and have been treated with a loading dose of a thienopyridine or on a maintenance dose of a thienopyridine.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): August 11, 2014
• Last Update Submitted That Met QC Criteria: August 8, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Platelet reactivity; Thienopyridine resistance; Aspirin resistance
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: VASP