Platelet Reactivity After CABG
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ClinicalTrials.gov Identifier: NCT01793597 |
Recruitment Status
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Completed
First Posted
: February 15, 2013
Last Update Posted
: September 22, 2015
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Sponsor:
University of Vermont
Information provided by (Responsible Party):
David J. Schneider, MD, University of Vermont
Tracking Information | |||
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First Submitted Date | February 13, 2013 | ||
First Posted Date | February 15, 2013 | ||
Last Update Posted Date | September 22, 2015 | ||
Study Start Date | May 2013 | ||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||
Change History | Complete list of historical versions of study NCT01793597 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Outcome Measures | Not Provided | ||
Original Other Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Platelet Reactivity After CABG | ||
Official Title | 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 | Observational | ||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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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. |
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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 | Acute Coronary Syndrome | ||
Intervention | Not Provided | ||
Study Groups/Cohorts |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
18 | ||
Original Estimated Enrollment |
50 | ||
Actual Study Completion Date | September 2015 | ||
Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT01793597 | ||
Other Study ID Numbers | ISSBRIL0095 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | David J. Schneider, MD, University of Vermont | ||
Study Sponsor | University of Vermont | ||
Collaborators | Not Provided | ||
Investigators | Not Provided | ||
PRS Account | University of Vermont | ||
Verification Date | September 2015 |