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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by University of Vermont
Sponsor:
Information provided by (Responsible Party):
David J. Schneider, MD, University of Vermont
ClinicalTrials.gov Identifier:
NCT01793597
First received: February 13, 2013
Last updated: February 14, 2013
Last verified: February 2013

February 13, 2013
February 14, 2013
March 2013
March 2014   (final data collection date for primary outcome measure)
reactivity of juvenile platelets [ Time Frame: 16-24 hours after CABG ] [ Designated as safety issue: No ]
We will use flow cytometry to identify juvenile platelets and assess their likelihood to activate in response to a submaximal concentration of agonist.
Same as current
Complete list of historical versions of study NCT01793597 on ClinicalTrials.gov Archive Site
  • platelet-leukocyte aggregates [ Time Frame: 16-24 hours after CABG ] [ Designated as safety issue: No ]
    We will identify the prevalence of platelet-leukocyte aggregates - a marker of platelet activation in vivo
  • platelet microparticles [ Time Frame: 16-24 hours after CABG ] [ Designated as safety issue: No ]
    We will quantify the prevalence of platelet microparticles, reflecting platelet activation in vivo
  • cytokine/chemokine array [ Time Frame: 16-24 hours after CABG ] [ Designated as safety issue: No ]
    We will quantify the concentration of common cytokines and chemokines.
Same as current
Not Provided
Not Provided
 
Platelet Activation, Reactivity, and Inflammation After Coronary Bypass Surgery In Patients Treated With Ticagrelor or Clopidogrel
Not Provided

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Platelets and leukocytes will be evaluated acutely. Plasma will be stored for cytokine and chemokine analysis.

Non-Probability Sample

Patients with acute coronary syndrome who based on clinical indications require urgent CABG. CABG is scheduled for clinical indications within 48 hours. Previous treatment with clopidogrel or ticagrelor.

Acute Coronary Syndrome
Not Provided
  • clopidogrel
    previous treatment with clopidogrel
  • ticagrelor
    previous treatment with ticagrelor
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01793597
ISSBRIL0095
No
David J. Schneider, MD, University of Vermont
University of Vermont
Not Provided
Not Provided
University of Vermont
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP