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Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting

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ClinicalTrials.gov Identifier: NCT02482857
Recruitment Status : Completed
First Posted : June 26, 2015
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Magnus Dalén, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE June 24, 2015
First Posted Date  ICMJE June 26, 2015
Last Update Posted Date March 8, 2018
Study Start Date  ICMJE December 2011
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
Serum thromboxane B2 [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02482857 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
Multiple electrode aggregometry platelet aggregation [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • Multiple electrode aggregometry platelet aggregation [ Time Frame: 3 months ]
  • Platelet P-selectin expression and fibrinogen binding by whole blood flow cytometry [ Time Frame: 3 months ]
    Without and with agonist stimulation by ADP, thrombin and U46619 (thromboxane analog)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
Official Title  ICMJE Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Bypass Surgery
  • Stable Angina
Intervention  ICMJE Drug: Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Other Name: Aspirin
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Acetylsalicylic acid
  • Active Comparator: Acetylsalicylic acid 160 mg once daily
    Aspirin 160 mg OD is an accepted and used dosage after CABG.
    Intervention: Drug: Acetylsalicylic acid
  • Active Comparator: Acetylsalicylic acid 75 mg once daily
    Aspirin 75 mg OD is an accepted and used dosage after CABG.
    Intervention: Drug: Acetylsalicylic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02482857
Other Study ID Numbers  ICMJE ASA-dos
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Magnus Dalén, Karolinska University Hospital
Study Sponsor  ICMJE Karolinska University Hospital
Collaborators  ICMJE Karolinska Institutet
Investigators  ICMJE
Principal Investigator: Paul Hjemdahl, Professor Karolinska University Hospital
PRS Account Karolinska University Hospital
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP