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OpenTrials
Completed

NCT Number: NCT01793597

Platelet Reactivity After CABG

Patients who have a heart attack are regularly treated with either clopidogrel or ticagrelor. In a large clinical trial, treatment with ticagrelor before coronary bypass surgery (CABG) was associated with a lower risk of death than treatment with clopidogrel. The reason for this difference cannot be explained on the basis of the study. One possible explanation is that the reversible binding of ticagrelor is advantageous because when new platelets are released, they are inhibited by the drug. Because clopidogrel binds irreversibly it cannot redistribute. The investigators will recruit patients who are scheduled for surgery after an acute coronary syndrome who have been treated with either ticagrelor or clopidogrel. After the patient provides informed consent, the investigators will review their medical record,record information and on the day after surgery the investigators will take one sample of blood. That blood will be analyzed for evidence of platelet activation (platelet microparticles, and platelet-leukocyte aggregates), the reactivity of young platelets, and the concentration of inflammatory cytokines. The investigators hypothesize that the evidence of platelet activation (platelet microparticles and platelet-leukocyte aggregates) and the reactivity of young platelets will be less in patients who have been treated previously with ticagrelor.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Acute coronary syndrome, CABG, within 48 hours of last dose of clopidogrel or ticagrelor, treatment with aspirin

Exclusion criteria

  • Treatment with an antiplatelet agent other than aspirin, clopidogrel, or ticagrelor, Acute or chronic hematologic disorder including a preoperative Hgb less than 10 g/dl or platelet count less than 100,000/mm3, Moderate or severe renal insufficiency (glomerular filtration rate less than 60 ml/min), Active infection, Active malignancy, Unable/unwilling to provide informed consent

Treatment and study plan

Primary outcomes

  1. reactivity of juvenile platelets

    Time frame: 16-24 hours after CABG

    We will use flow cytometry to identify juvenile platelets and assess their likelihood to activate in response to a submaximal concentration of agonist.

Secondary outcomes

  1. platelet-leukocyte aggregates

    Time frame: 16-24 hours after CABG

    We will identify the prevalence of platelet-leukocyte aggregates - a marker of platelet activation in vivo

  2. platelet microparticles

    Time frame: 16-24 hours after CABG

    We will quantify the prevalence of platelet microparticles, reflecting platelet activation in vivo

  3. cytokine/chemokine array

    Time frame: 16-24 hours after CABG

    We will quantify the concentration of common cytokines and chemokines.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

Platelet Activation, Reactivity, and Inflammation After Coronary Bypass Surgery In Patients Treated With Ticagrelor or Clopidogrel

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 15, 2013
Registry last updated
Sep 22, 2015

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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