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Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting

Primary Purpose

Coronary Artery Bypass Surgery, Stable Angina

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acetylsalicylic acid
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Bypass Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable coronary artery disease
  • ≥18 years of age
  • Scheduled to undergo elective CABG surgery
  • Willing to participate and able to provide informed consent

Exclusion Criteria:

  • Intake of drugs other than ASA that are known to influence platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), GPIIbIIIa inhibitors, clopidogrel, dipyridamole, warfarin or acenocoumarol within 7 days of enrolment
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Acetylsalicylic acid 75 mg twice daily

    Acetylsalicylic acid 160 mg once daily

    Acetylsalicylic acid 75 mg once daily

    Arm Description

    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.

    Aspirin 160 mg OD is an accepted and used dosage after CABG.

    Aspirin 75 mg OD is an accepted and used dosage after CABG.

    Outcomes

    Primary Outcome Measures

    Serum thromboxane B2

    Secondary Outcome Measures

    Multiple electrode aggregometry platelet aggregation

    Full Information

    First Posted
    June 24, 2015
    Last Updated
    March 6, 2018
    Sponsor
    Karolinska University Hospital
    Collaborators
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02482857
    Brief Title
    Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
    Official Title
    Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    July 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska University Hospital
    Collaborators
    Karolinska Institutet

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a single-center, open-label, randomized controlled trial. Patients with stable angina pectoris without use of dual antiplatelet therapy or anticoagulation therapy scheduled for coronary artery bypass grafting (CABG) at Karolinska University Hospital in Stockholm, Sweden will be eligible. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Bypass Surgery, Stable Angina

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Acetylsalicylic acid 75 mg twice daily
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Acetylsalicylic acid 160 mg once daily
    Arm Type
    Active Comparator
    Arm Description
    Aspirin 160 mg OD is an accepted and used dosage after CABG.
    Arm Title
    Acetylsalicylic acid 75 mg once daily
    Arm Type
    Active Comparator
    Arm Description
    Aspirin 75 mg OD is an accepted and used dosage after CABG.
    Intervention Type
    Drug
    Intervention Name(s)
    Acetylsalicylic acid
    Other Intervention Name(s)
    Aspirin
    Intervention Description
    To compare BID dosing with OD dosing with clinically used aspirin dosages.
    Primary Outcome Measure Information:
    Title
    Serum thromboxane B2
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Multiple electrode aggregometry platelet aggregation
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Stable coronary artery disease ≥18 years of age Scheduled to undergo elective CABG surgery Willing to participate and able to provide informed consent Exclusion Criteria: Intake of drugs other than ASA that are known to influence platelet function, including nonsteroidal anti-inflammatory drugs (NSAIDs, including COX-2 selective anti-inflammatory drugs), GPIIbIIIa inhibitors, clopidogrel, dipyridamole, warfarin or acenocoumarol within 7 days of enrolment 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Hjemdahl, Professor
    Organizational Affiliation
    Karolinska University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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