Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
NCT ID: NCT02482857
Last Updated: 2018-03-08
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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COMPLETED
PHASE2/PHASE3
45 participants
INTERVENTIONAL
2011-12-31
2015-07-31
Brief Summary
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This study investigates in patients having undergone CABG whether increasing the dose or the frequency of acetylsalicylic acid (ASA) treatment improves the efficacy of ASA regarding platelet inhibition compared to the standard dosing for cardiovascular prevention (75 mg once daily) in the first three months after surgery. Patients will be randomly assigned to postoperative ASA dose 75mg once daily, 75mg twice daily or 160 mg once daily. The study dose ASA will be started at hospital discharge and continued of three months. Blood samples for serum thromboxane B2 (TxB2) and other analyses will be taken before surgery, before discharge, and after one and three months. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acetylsalicylic acid 75 mg twice daily
Aspirin 75 mg BID is a new experimental dosing regimen which has shown improved efficiency regarding laboratory parameters in several studies, mainly in diabetic patients.
Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Acetylsalicylic acid 160 mg once daily
Aspirin 160 mg OD is an accepted and used dosage after CABG.
Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Acetylsalicylic acid 75 mg once daily
Aspirin 75 mg OD is an accepted and used dosage after CABG.
Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Interventions
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Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥18 years of age
* Scheduled to undergo elective CABG surgery
* Willing to participate and able to provide informed consent
Exclusion Criteria
* Hemorrhagic diathesis or known platelet dysfunction
* Chronic renal failure requiring dialysis
* Platelet count outside the 100 000 to 450 000/μL range
* Haemoglobin \< 8g/dl
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Magnus Dalén
MD, PhD
Principal Investigators
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Paul Hjemdahl, Professor
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Other Identifiers
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ASA-dos
Identifier Type: -
Identifier Source: org_study_id
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