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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Medstar Research Institute
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01408927
First received: July 28, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Increased Drug Resistance
Other: Thienopyridine resistance testing
Other: Aspirin resistance testing
Other: Genetic polymorphism assessment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Level of Thienopyridine Resistance Seen in a Contemporary PCI and CABG Population

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • The prevalence and degree of thienopyridine resistance [ Time Frame: Duration of hospital stay; average hospital stay of less than 48 hours ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • The prevalence of aspirin resistance [ Time Frame: Duration of hospital stay; average hospital stay of less than 48 hours ] [ Designated as safety issue: No ]
    The prevalence and degree of aspirin resistance will be measured by the VerifyNow aspirin resistance assay.

  • Correlate levels of platelet reactivity with the presence of selected genetic polymorphisms [ Time Frame: Duration of hospital stay; average hospital stay of less than 48 hours ] [ Designated as safety issue: No ]
    The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.


Estimated Enrollment: 1000
Study Start Date: October 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other: Aspirin resistance testing
    Aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
    Other: Genetic polymorphism assessment
    The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408927

Contacts
Contact: Ron Waksman, MD 202-877-5975 ron.waksman@medstar.net

Locations
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ron Waksman, MD    202-877-5975    ron.waksman@medstar.net   
Principal Investigator: Ron Waksman, MD         
Sponsors and Collaborators
Medstar Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01408927     History of Changes
Other Study ID Numbers: VASP
Study First Received: July 28, 2011
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar Research Institute:
Thienopyridine resistance
Aspirin resistance
Platelet reactivity

Additional relevant MeSH terms:
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 31, 2014