NCT07195149 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)
| NCT ID | NCT07195149 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. |
| Condition | Chronic Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,703 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,703 participants in total. It began in 2025-11-25 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: A. Baseline (preoperative) 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. B. Operative inclusion criteria: 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: A. Baseline (preoperative) 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). B. Postoperative and prior randomization exclusion criteria: 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
Contact & Investigator
Sleiman Sebastian Aboul-Hassan, MD, PhD
PRINCIPAL INVESTIGATOR
Zbigniew Religa Heart Center "Medinet"
Frequently Asked Questions
Who can join the NCT07195149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07195149 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,703 participants.
Is NCT07195149 currently recruiting?
Yes, NCT07195149 is actively recruiting participants. Contact the research team at badaniakliniczne@medinet.pl for enrollment information.
Where is the NCT07195149 trial being conducted?
This trial is being conducted at Bialystok, Poland, Bydgoszcz, Poland, Gdansk, Poland, Grudziądz, Poland and 11 additional locations.
Who is sponsoring the NCT07195149 clinical trial?
NCT07195149 is sponsored by Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.. The principal investigator is Sleiman Sebastian Aboul-Hassan, MD, PhD at Zbigniew Religa Heart Center "Medinet". The trial plans to enroll 1,703 participants.