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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

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Surgery Stable Angina Drug: Acetylsalicylic acid Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
Study Start Date : December 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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 Name: 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 Name: 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 Name: Aspirin




Primary Outcome Measures :
  1. Serum thromboxane B2 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Multiple electrode aggregometry platelet aggregation [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482857


Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
Principal Investigator: Paul Hjemdahl, Professor Karolinska University Hospital

Responsible Party: Magnus Dalén, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02482857     History of Changes
Other Study ID Numbers: ASA-dos
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Angina, Stable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics