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NCT Number: NCT02482857

Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting

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.

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Key information

Conditions

Coronary Artery Bypass Surgery Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acetylsalicylic acid

Drug

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

Other names: Aspirin

Primary outcomes

  1. Serum thromboxane B2

    Time frame: 3 months

Secondary outcomes

  1. Multiple electrode aggregometry platelet aggregation

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jun 26, 2015
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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