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Completed

NCT Number: NCT01406483

Platelet Reactivity in Patients on a Thienopyridine and Awaiting Coronary Artery Bypass Grafting

The primary objective of this exploratory cohort study is to describe levels of platelet reactivity in patients on a thienopyridine awaiting coronary artery bypass grafting (CABG).

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Key information

About this study

The recent emergence of platelet reactivity testing as a potential option for evaluating the degree of platelet inhibition promises to add another level of understanding to our concept of CABG-related bleeding. There is an emerging literature that links high levels of platelet reactivity with adverse clinical events, primarily in patients on clopidogrel.

For example, studies of the VerifyNow P2Y12 platelet function assay have shown that Platelet Reactivity Units (PRU) > 235-240 in patients on clopidogrel therapy appears to predict cardiovascular events.15,16 There is a paucity of literature, however, on the use of platelet reactivity testing to predict bleeding events and complications. In other words, if excessively high levels of platelet reactivity predict ischemic events, do excessively low levels of platelet reactivity predict bleeding events? This is an especially relevant question, given the emergence of prasugrel as a therapeutic option.

The investigators therefore propose an exploratory cohort study of patients receiving a thienopyridine (clopidogrel or prasugrel) and undergoing CABG, in order to describe levels of platelet reactivity in such patients by using a variety of platelet function tests.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years old from both genders.
  • Taking maintenance thienopyridine therapy within 5 days of surgery OR received a loading dose of thienopyridine therapy within 48 hours of surgery for CABG.
  • Referred for CABG (which is scheduled to be performed during the current admission).

Exclusion criteria

  • Known allergies to aspirin, clopidogrel, or prasugrel.
  • Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of initial platelet reactivity testing.
  • Patient known to be pregnant or lactating.
  • Patient with known history of bleeding diathesis or currently active bleeding.
  • Platelet count <100,000/mm the day of initial blood draw.
  • Hematocrit <25% the day of initial blood draw.
  • On warfarin therapy at the time of initial blood draw.
  • Known blood transfusion within the preceding 10 days of the blood draw.
  • Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
  • Plan for patient to be discharged before undergoing CABG.
  • Any significant medical condition that, in the investigator's opinion, may interfere with the patient's optimal participation in the study.

Treatment and study plan

Platelet reactivity assessment

Other

Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay.

Primary outcomes

  1. Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer

    Time frame: Duration of hospital stay; average hospital stay of 1 week

    Serial levels of platelet reactivity, as assessed with the Chrono-log Lumi-Aggregometer, which measures levels of light transmittance after stimulation with ADP to estimate levels of platelet aggregation

  2. Perioperative rates of bleeding complications

    Time frame: Duration of hospital stay; average hospital stay of 1 week

    Perioperative rates of bleeding complications:

    • need for reoperation because of bleeding
    • need for perioperative red blood cell transfusion (units of packed red blood cells)
    • rates of TIMI, GUSTO, and nuisance bleeding
    • quantity of postoperative drainage (mL)

Secondary outcomes

  1. Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay

    Time frame: Duration of hospital stay; average hospital stay of 1 week

    Serial levels of platelet reactivity, as assessed with the VerifyNow P2Y12 assay, which measures platelet reactivity units (PRUs)

  2. Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay

    Time frame: Duration of hospital stay; average hospital stay of 1 week

    Serial levels of platelet reactivity, as assessed with the Vasodilator Stimulated Phosphoprotein (VASP) assay, which measures percentage of platelet reactivity inhibition (PRI) by flow cytometry of the VASP-P protein

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Acronym: Serial CABG

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2011
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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