Stable Angina Clinical Trial
Official title:
Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting
Verified date | March 2018 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 45 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Karolinska Institutet |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum thromboxane B2 | 3 months | ||
Secondary | Multiple electrode aggregometry platelet aggregation | 3 months |
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