Antiplatelet Effect of Low Doses of Aspirin Taken Every 12 Hours in Patients Undergoing Coronary Artery Bypass Graft and/or Aortic Valve Surgery
NCT ID: NCT01466452
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
99 participants
INTERVENTIONAL
2011-09-30
2013-09-30
Brief Summary
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The aims of the study are:
* to establish whether coronary artery bypass surgery and / or aortic valve replacement surgery with bioprostheses is associated with changes in the rate of platelet regeneration that can reduce the effectiveness of aspirin administered at a dose of 100mg/die in terms of inhibition of platelet biosynthesis of thromboxane A2.
* to determine whether these patients need a different (shorter) interval of administration in order to completely and permanently inhibit the platelet COX-1.
The endpoints of this study are:
\- To evaluate the changes in the levels of TXB2 and 12-HETE in serum at 12 and 24 hours after administration of aspirin and the changes in the levels of 11-dehydro TXB2 urinary 8-iso-PGF2 alpha urinary, 2-3 dinor-6-chetoPGF1 alpha, Verify-NOW Aspirin, platelets crosslinked at 12 and 24 hours after administration of aspirin
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Aspirin 100
Aspirin
single-dose aspirin in 100 mg 1 tablet every 24 hours
Aspirin 200
Aspirin
single-dose aspirin 200 mg 1 tablet every 24 hours
Aspirin 100 x 2
Aspirin
double-dose aspirin 100 mg 1 tablet every 12 hours
Interventions
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Aspirin
single-dose aspirin in 100 mg 1 tablet every 24 hours
Aspirin
single-dose aspirin 200 mg 1 tablet every 24 hours
Aspirin
double-dose aspirin 100 mg 1 tablet every 12 hours
Eligibility Criteria
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Inclusion Criteria
* coronary artery bypass graft and / or aortic valve replacement surgery with bioprostheses
* age between 55 and 80
* ejection fraction \> 30%.
Exclusion Criteria
* perioperative myocardial infarction
* stroke or renal failure requiring dialysis and need waiting for post-operative anticoagulation
* patients undergoing coronary artery bypass grafting procedure as a consequence of failed percutaneous coronary intervention
* patients undergoing off-pump coronary artery bypass graft
* overt kidney or liver disease
* therapies that influence the coagulation
* fertile women
55 Years
80 Years
ALL
No
Sponsors
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Catholic University, Italy
OTHER
University of Chieti
OTHER
Centro Cardiologico Monzino
OTHER
Responsible Party
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Alessandro Parolari
Assistant Professor of Cardiac Surgery
Locations
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Centro Cardiologico Monzino, IRCCS
Milan, Milano, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S181/211
Identifier Type: -
Identifier Source: org_study_id