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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02293928 |
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Date of registration:
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13/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Hybrid Coronary Revascularization on Antiplatelet Therapy
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Scientific title:
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Impact of Hybrid Coronary Revascularization on Antiplatelet Effect of Aspirin and Clopidogrel |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02293928 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Ivy S Modrau, MD, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Aarhus University Hospitak Skejby |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- symptomatic multivessel coronary artery disease
- treatment with non-enteric coated aspirin 75 mg once daily
Exclusion Criteria:
- aspirin or clopidogrel intolerance
- conditions prohibitive of aspirin discontinuation prior to surgery
- use of anticoagulants or any drugs other than aspirin known to affect platelet
function
- use of immunosuppressive drugs
- platelet count <100 or >450 x 109/l
- inability to give informed consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Procedure: Hybrid coronary revascularization
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Primary Outcome(s)
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Change in aspirin antiplatelet effect from preoperative to three days postoperative
[Time Frame: 12-14 days]
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Secondary Outcome(s)
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Association between baseline platelet aggregation (off-aspirin) and aspirin antiplatelet effect
[Time Frame: 12-14 days]
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Correlation between acute phase reactants and platelet aggregation
[Time Frame: 8-10 days preoperative until 1 year postoperative]
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Change on clopidogrel antiplatelet effect from first day after PCI to 1 year follow-up
[Time Frame: 1 year]
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Change on aspirin antiplatelet effect from 3 days postoperative to 1 year follow-up
[Time Frame: 1 year]
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Correlation between platelet turnover and platelet aggregation
[Time Frame: 8-10 days preoperative until 1 year postoperative]
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Secondary ID(s)
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10-000439
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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