Platelet Activation, Reactivity, and Inflammation After Coronary Bypass Surgery In Patients Treated With Ticagrelor or Clopidogrel
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Purpose
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.
| Condition |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
Platelets and leukocytes will be evaluated acutely. Plasma will be stored for cytokine and chemokine analysis.
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
clopidogrel
previous treatment with clopidogrel
|
|
ticagrelor
previous treatment with ticagrelor
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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
Contacts and Locations| United States, Vermont | |
| Fletcher Allen Health Care | Not yet recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: David J Schneider, MD 802-847-3734 david.schneider@uvm.edu | |
| Principal Investigator: David J Schneider, MD | |
More Information
No publications provided
| Responsible Party: | David J. Schneider, MD, Professor Of Medicine, Director of Cardiology, University of Vermont |
| ClinicalTrials.gov Identifier: | NCT01793597 History of Changes |
| Other Study ID Numbers: | ISSBRIL0095 |
| Study First Received: | February 13, 2013 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Vermont:
|
ticagrelor Coronary artery bypass surgery platelet function |
receptor binding platelet reactivity reversible binding |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms Clopidogrel Ticagrelor |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013