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Platelet Reactivity After CABG
This study has been completed.
Sponsor:
University of Vermont
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
| 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 |
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 ICMJE | Same as current | ||
| Change History | Complete list of historical versions of study NCT01793597 on ClinicalTrials.gov Archive Site | ||
| Current Secondary Outcome Measures ICMJE |
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| 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 |
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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 ICMJE | Acute Coronary Syndrome | ||
| Intervention ICMJE | Not Provided | ||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||
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* 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 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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||
| U.S. FDA-regulated Product | Not Provided | ||
| 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 | ||
| PRS Account | University of Vermont | ||
| Verification Date | September 2015 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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