Platelet Reactivity After CABG

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

David J. Schneider, MD, University of Vermont

ClinicalTrials.gov Identifier:

NCT01793597

First received: February 13, 2013

Last updated: September 20, 2015

Last verified: September 2015

History of Changes

Tracking Information
First Received Date ^ICMJE	February 13, 2013
Last Updated Date	September 20, 2015
Start Date ^ICMJE	May 2013
Primary Completion Date	September 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 14, 2013)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01793597 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 14, 2013)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Platelet Reactivity After CABG
Official Title ^ICMJE	Platelet Activation, Reactivity, and Inflammation After Coronary Bypass Surgery In Patients Treated With Ticagrelor or Clopidogrel
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Platelets and leukocytes will be evaluated acutely. Plasma will be stored for cytokine and chemokine analysis.
Sampling Method	Non-Probability Sample
Study Population	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.
Condition ^ICMJE	Acute Coronary Syndrome
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	clopidogrel previous treatment with clopidogrel ticagrelor previous treatment with ticagrelor
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	18
Completion Date	September 2015
Primary Completion Date	September 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01793597
Other Study ID Numbers ^ICMJE	ISSBRIL0095
Has Data Monitoring Committee	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	David J. Schneider, MD, University of Vermont
Study Sponsor ^ICMJE	University of Vermont
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Vermont
Verification Date	September 2015
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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