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NCT07195149RecruitingPhase 3

Optimal antiplatelet therapy in patients after coronary artery bypass grafting.

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).

Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 Nov 2025

Brief summary (registry, in English)

To compare the effect of low-dose ASA plus prasugrel with low-dose ASA and with high-dose ASA for 3 months followed by low-dose aspirin alone on graft failure in patients with stable coronary artery disease undergoing randomization following CABG procedure.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1703 (estimated)
First submitted
13 May 2025
Start date
24 Nov 2025
Lead sponsor
Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.
EU CT number
2025-521892-30-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1703
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Postoperative and prior randomization exclusion criteria: 1. 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
  • Atrial Fibrillation prior randomization
    • Single vessel CABG

Other illness

  • Active malignant disease or history of malignancy within the past 5 years
  • Planned additional cardiac or non-cardiac surgery within 12 months
  • Non-cardiac co-morbidity with life expectancy less than 12 months
  • History of any bleeding complications due to the use of DAPT
  • History of intracranial bleeding
  • History of gastro-intestinal bleeding
  • Patients with recent acute coronary syndrome (ACS) (<12 months)

Lab values

  • Severe impaired renal function (eGFR <40ml/min/1.73 m2).
  • Gastro-intestinal bleeding prior randomization
    • Patients with preoperative atrial fibrillation
    • Dialysis
    • 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

Other

  • Baseline (preoperative) exclusion criteria: 1. Cardiogenic shock
  • Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
  • Indication for oral anticoagulant treatment
  • Indications for the use of methotrexate at a dose of 15 mg/week or more
  • Any contraindication for prasugrel or ASA
  • Pregnancy or breastfeeding
  • Lack of compliance with the use of a highly effective method of birth control
  • Planned coronary endarterectomy
  • Any postoperative complication that may increase patients’ risk with DAPT

Who the study is looking for

  • 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:  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
  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (18)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandRecruiting
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
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BydgoszczPolandRecruiting
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
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GrudziądzPolandRecruiting
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandRecruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandRecruiting
Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.
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Nowa SolPolandRecruiting
Wojewódzki Szpital Specjalistyczny w Olsztynie
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OlsztynPolandRecruiting
Uniwersytecki Szpital Kliniczny w Opolu
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OpolePolandRecruiting
Wielospecjalistyczny Szpital Miejski Im. Jozefa Strusia Z Zakladem Opiekunczo Leczniczym. Samodzielny Publiczny Zaklad Opieki Zdrowotnej Z Siedziba W Poznaniu Przy Ul. Szwajcarskiej 3
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PoznanPolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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SzczecinPolandRecruiting
Wielospecjalistyczny Szpital Medicover
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WarsawPolandRecruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.
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WroclawPolandRecruiting
Śląskie Centrum Chorób Serca w Zabrzu
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ZabrzePolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.