Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)

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

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1703 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2030-11-30

Brief Summary

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The purpose of this study is to compare the effect of prasugrel plus low-dose aspirin versus high dose aspirin alone (300mg) and versus low dose aspirin alone (75 mg) in patients with chronic coronary disease undergoing coronary artery bypass grafting.

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Detailed Description

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This is a multicenter, randomized trial evaluating the effect of low-dose aspirin plus prasugrel versus low-dose ASA and versus high-dose ASA for three months, followed by low-dose ASA alone, on graft failure at 12 months in patients with stable coronary artery disease (chronic coronary syndrome) following a coronary artery bypass grafting.

Conditions

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Chronic Coronary Syndrome Stable Coronary Artery Disease CAD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prasugrel 10 mg + Low Dose Aspirin 75 mg

Group Type EXPERIMENTAL

DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg)

Intervention Type DRUG

Drug: Prasugrel 10 mg

Prasugrel 10 mg once daily taken orally for 3 months

Drug: Low-Dose Aspirin

75 mg once daily taken orally

Low-Dose Aspirin 75 mg

Group Type ACTIVE_COMPARATOR

Low-Dose Aspirin 75 mg

Intervention Type DRUG

Low-Dose Aspirin 75 mg once daily taken orally

High-Dose Aspirin 300 mg

Group Type ACTIVE_COMPARATOR

High-Dose Aspirin 300 mg

Intervention Type DRUG

High-dose Aspirin 300 mg once daily taken orally for three months

Interventions

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High-Dose Aspirin 300 mg

High-dose Aspirin 300 mg once daily taken orally for three months

Intervention Type DRUG

DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg)

Drug: Prasugrel 10 mg

Prasugrel 10 mg once daily taken orally for 3 months

Drug: Low-Dose Aspirin

75 mg once daily taken orally

Intervention Type DRUG

Low-Dose Aspirin 75 mg

Low-Dose Aspirin 75 mg once daily taken orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 years
2. Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts. Coronary artery disease will be defined as a stenosis ≥ 70% based on coronary angiography, a FFR value ≤ 0.80 or iFr value ≤0.89; a left main diameter stenosis ≥ 50%, left main IVUS MLA value ≤ 6 mm2, or equivalent OCT measurements will also be considered.
3. Ability to comply with all study procedures and follow-up procedures
4. Signed Informed Consent to participate in the study.

1. Intraoperative graft evaluation using transit time flow measurement in all grafts, normal flow in any graft is defined as mean graft flow \> 15 mL/min with Pulsatility Index \< 5
2. Left anterior descending artery grafted with internal thoracic artery
3. No intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel)
4. No endarterectomy of the grafted vessel performed
5. Patient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention)

Exclusion Criteria

1. Cardiogenic shock
2. Patients with recent acute coronary syndrome (ACS) (\<12 months)
3. Single vessel CABG
4. Patients with preoperative atrial fibrillation
5. Dialysis
6. Thrombocytopenia (platelet count \< 100 000 platelets/uL)
7. Anemia (Hemoglobin level \< 10 g/dL)
8. Severe liver failure Child-Pugh classification \>4
9. Known, active infections with HIV, HBV, HCV, tuberculosis
10. Active malignant disease or history of malignancy within the past 5 years
11. Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
12. Indication for oral anticoagulant treatment 13 Indications for the use of methotrexate at a dose of 15 mg/week or more

14\. Any contraindication for prasugrel or ASA 15. Planned additional cardiac or non-cardiac surgery within 12 months 16. Non-cardiac co-morbidity with life expectancy less than 12 months 17. History of any bleeding complications due to the use of DAPT 18. History of intracranial bleeding 19. History of gastro-intestinal bleeding 20. Pregnancy or breastfeeding 21. Lack of compliance with the use of a highly effective method of birth control 22. Planned coronary endarterectomy 23. Severe impaired renal function (eGFR \<40mL/min/1.73 m2).

1. Perioperative cardiogenic shock
2. Intraoperative death or death prior randomization
3. Myocardial infarction within 12-24 hours following CABG or prior randomization
4. Ischemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization
5. Any postoperative complication that may increase patients' risk with DAPT
6. Atrial Fibrillation prior randomization
7. Gastro-intestinal bleeding prior randomization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Sleiman Sebastian Aboul-Hassan

Principal Investigator: Sleiman Sebastian Aboul-Hassan MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sleiman Sebastian Aboul-Hassan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zbigniew Religa Heart Center "Medinet"

Locations

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