Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting

March 6, 2018 updated by: Magnus Dalén, Karolinska University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Other Names:
  • Aspirin
Active Comparator: Acetylsalicylic acid 160 mg once daily
Aspirin 160 mg OD is an accepted and used dosage after CABG.
Drug: Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Other Names:
  • Aspirin
Active Comparator: Acetylsalicylic acid 75 mg once daily
Aspirin 75 mg OD is an accepted and used dosage after CABG.
Drug: Acetylsalicylic acid
To compare BID dosing with OD dosing with clinically used aspirin dosages.
Other Names:
  • Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum thromboxane B2
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Multiple electrode aggregometry platelet aggregation
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Paul Hjemdahl, Professor, Karolinska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASA-dos

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stable Angina

Clinical Trials on Acetylsalicylic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe