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Chronic Coronary SyndromePhase 3OPTIMUS-CABGNCT07195149

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)

A Phase 3 study testing High-Dose Aspirin 300 mg, DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg) and Low-Dose Aspirin 75 mg in people with Chronic Coronary Syndrome and Stable Coronary Artery Disease CAD, run by Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. at 18 sites in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High-Dose Aspirin 300 mg, DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg) and Low-Dose Aspirin 75 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,703 participants
Where
18 sitesPoland
Study dates
25 Nov 2025to 30 Nov 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Baseline (preoperative) inclusion criteria
  • Age >18 years
  • 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.
  • Ability to comply with all study procedures and follow-up procedures
  • Signed Informed Consent to participate in the study.
  • Operative inclusion criteria:
Show all 11Show fewer
  • 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
  • Left anterior descending artery grafted with internal thoracic artery
  • No intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel)
  • No endarterectomy of the grafted vessel performed
  • Patient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention)

Who cannot join

  • Baseline (preoperative) exclusion criteria:
  • Cardiogenic shock
  • Patients with recent acute coronary syndrome (ACS) (<12 months)
  • Single vessel CABG
  • Patients with preoperative atrial fibrillation
  • Dialysis
Show all 22Show fewer
  • Thrombocytopenia (platelet count < 100 000 platelets/uL)
  • Anemia (Hemoglobin level < 10 g/dL)
  • Severe liver failure Child-Pugh classification >4
  • Known, active infections with HIV, HBV, HCV, tuberculosis
  • Active malignant disease or history of malignancy within the past 5 years
  • Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
  • 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).
  • Postoperative and prior randomization exclusion criteria:
  • Perioperative cardiogenic shock
  • Intraoperative death or death prior randomization
  • Myocardial infarction within 12-24 hours following CABG or prior randomization
  • Ischemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization
  • Any postoperative complication that may increase patients' risk with DAPT
  • Atrial Fibrillation prior randomization
  • Gastro-intestinal bleeding prior randomization

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aleksandra Pawlik contact

+48 71 320 94 50

badaniakliniczne@medinet.pl

18 sites in 1 country

Poland18 sites, 16 recruiting

  • University Clinical Hospital in Bialystok

    Bialystok

    Active, not recruiting

  • Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz

    Bydgoszcz

    Wojciech Pawliszak, MD, PhD

    Not yet recruiting

  • Medical University of Gdansk

    Gdansk

    Andrzej Los, MD, PhD

    Not yet recruiting

  • Regional Specialist Hospital in Grudziadz

    Grudziądz

    Marian Burysz, MD, PhD

    Not yet recruiting

  • Upper-Silesian Heart Center

    Katowice

    Radoslaw Gocol, MD, PhD

    Recruiting

  • John Paul II Hospital

    Krakow

    Janusz Konstanty-Kalandyk, MD, PhD

    Not yet recruiting

  • Medical University of Lodz

    Lodz

    Michal Krejca, MD, PhD

    Not yet recruiting

  • Zbigniew Religa Heart Center "Medinet"

    Nowa Sól

    Sleiman Sebastian Aboul-Hassan, MD, PhD

    Recruiting

  • Provincial Specialist Hospital in Olsztyn

    Olsztyn

    Anna Witt-Majchrzak, MD, PhD

    Not yet recruiting

  • Institute of Medical Sciences in Opole

    Opole

    Marek Cisowski, MD, PhD

    Recruiting

  • J. Struś Hospital

    Poznan

    Pawel Bugajski, MD, PhD

    Not yet recruiting

  • Poznan University of Medical Sciences

    Poznan

    Active, not recruiting

  • Pomeranian Medical University

    Szczecin

    Jerzy Pacholewicz, MD, PhD

    Not yet recruiting

  • Central Clinical Hospital of the Ministry of Interior and Administration

    Warsaw

    Mariusz Kowalewski, MD, PhD

    Recruiting

  • Medicover Hospital

    Warsaw

    Krzysztof Wrobel, MD, PhD

    Recruiting

  • Wroclaw Medical University

    Wroclaw

    Maciej Bochenek, MD

    Recruiting

  • Zbigniew Religa Heart Center "Medinet"

    Wroclaw

    Mikolaj Berezowski, MD

    Recruiting

  • Silesian Centre for Heart Diseases in Zabrze

    Zabrze

    Tomasz Hrapkowicz, MD, PhD

    Recruiting

Other trials in Poland

About this study

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.

Read the detailed description

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.

Being tested
High-Dose Aspirin 300 mg, DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg), Low-Dose Aspirin 75 mg
Keywords
DAPT, CABG, Prasugrel, Aspirin, CCS, Chronic coronary syndrome, Stable coronary artery disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High-Dose Aspirin 300 mgDrug

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

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

    Low-Dose Aspirin 75 mg once daily taken orally

Study groups in NCT07195149
Study groupRoleWhat they receive
Prasugrel 10 mg + Low Dose Aspirin 75 mgExperimentalNot described
Receives: Drug: DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg)
Low-Dose Aspirin 75 mgActive comparatorNot described
Receives: Drug: Low-Dose Aspirin 75 mg
High-Dose Aspirin 300 mgActive comparatorNot described
Receives: Drug: High-Dose Aspirin 300 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin

    Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) versus high-dose aspirin (300mg/day) and in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) vs low-dose aspirin (75mg/day)

    Measured: 12 months

Secondary outcomes (5)

  1. Key secondary outcome: Incidence of graft failure: High-Dose Aspirin vs Low-Dose Aspirin

    Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with high-dose aspirin (300mg/day) vs low-dose aspirin (75mg/day)

    Measured: 12 months

  2. investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of ischemic events after CABG

    Major adverse cardiac and cerebral events (MACCE) is a composite endpoint to be compared between groups defined as composite of:

    1. All-cause mortality
    2. Incidence of myocardial infarction
    3. Incidence of stroke
    4. Incidence of repeat revascularization

    Measured: 12 months

  3. Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of bleeding events after CABG

    Incidence of bleeding within 12 months after randomization following CABG procedure according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5

    Measured: 12 months

  4. Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on quality of life at 6 and 12 months after CABG.

    Quality of life will be assessed using quality of life questionnaires at baseline, 6 and 12 months after randomization following CABG procedure and will be evaluated using The Seattle Angina Questionnaire - 7 (SAQ-7) and Short-form-12 health survey questionnaire (SF-12)

    Measured: 12 months

  5. investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 60-month risk of ischemic events after CABG

    Major adverse cardiac and cerebral events (MACCE) is a composite endpoint to be compared between groups defined as composite of:

    1. All-cause mortality
    2. Incidence of myocardial infarction
    3. Incidence of stroke
    4. Incidence of repeat revascularization

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start25 Nov 2025
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Nov 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,703 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195149
Sponsor's protocol ID
2024/ABM/01/00016
Other IDs
2025-521892-30-00, 2025
Acronym
OPTIMUS-CABG
Status last verified
Oct 2026
First submitted
15 Sep 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing High-Dose Aspirin 300 mg, DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg) and Low-Dose Aspirin 75 mg in people with Chronic Coronary Syndrome and Stable Coronary Artery Disease CAD, run by Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. at 18 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleksandra Pawlik (+48 71 320 94 50, badaniakliniczne@medinet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07195149.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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