Optimal Dose of Acetylsalicylic Acid After Coronary Artery Bypass Grafting

NCT ID: NCT02482857

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Bypass Surgery Stable Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Acetylsalicylic acid

Intervention Type DRUG

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

Acetylsalicylic acid 160 mg once daily

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

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type DRUG

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

Acetylsalicylic acid 75 mg once daily

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

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type DRUG

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

Interventions

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Acetylsalicylic acid

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

Intervention Type DRUG

Other Intervention Names

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Aspirin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnus Dalén

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paul Hjemdahl, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Other Identifiers

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ASA-dos

Identifier Type: -

Identifier Source: org_study_id

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