Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting

NCT02482857 | Completed Phase 2 DMC

• 1 other identifier: ASA-dos
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Bypass Surgery; Stable Angina

Outcome Measures

Primary Outcomes (1)

• Serum thromboxane B2

  3 months

Secondary Outcomes (1)

• Multiple electrode aggregometry platelet aggregation

  3 months

Study Arms (3)

Acetylsalicylic acid 75 mg twice daily

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.

Drug: Acetylsalicylic acid

Acetylsalicylic acid 160 mg once daily

ACTIVE COMPARATOR

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

Drug: Acetylsalicylic acid

Acetylsalicylic acid 75 mg once daily

ACTIVE COMPARATOR

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

Drug: Acetylsalicylic acid

Interventions

Acetylsalicylic acid DRUG

To compare BID dosing with OD dosing with clinically used aspirin dosages.

Also known as: Aspirin

Acetylsalicylic acid 160 mg once daily; Acetylsalicylic acid 75 mg once daily; Acetylsalicylic acid 75 mg twice daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

MeSH Terms

Conditions

Angina, Stable

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Paul Hjemdahl, Professor

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: December 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 8, 2018

Record last verified: 2018-03