Overview

This trial is active, not recruiting.

Condition stable coronary artery disease with coronary artery bypass grafting
Treatment acetylsalicylic acid
Phase phase 2/phase 3
Sponsor Karolinska University Hospital
Collaborator Karolinska Institutet
Start date December 2011
End date July 2015
Trial size 45 participants
Trial identifier NCT02482857, ASA-dos

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Aspirin
To compare BID dosing with OD dosing with clinically used aspirin dosages.
(Active Comparator)
Aspirin 160 mg OD is an accepted and used dosage after CABG.
acetylsalicylic acid Aspirin
To compare BID dosing with OD dosing with clinically used aspirin dosages.
(Active Comparator)
Aspirin 75 mg OD is an accepted and used dosage after CABG.
acetylsalicylic acid Aspirin
To compare BID dosing with OD dosing with clinically used aspirin dosages.

Primary Outcomes

Measure
Serum thromboxane B2
time frame: 3 months

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Karolinska University Hospital.