Actively Recruiting
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)
Led by Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o. · Updated on 2026-01-06
1703
Participants Needed
18
Research Sites
261 weeks
Total Duration
On this page
Sponsors
D
Dolnośląskie Centrum Chorób Serca im.prof. Zbigniewa Religi MEDINET Sp. z o.o.
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Patients scheduled for primary isolated coronary artery bypass grafting with stable coronary artery disease planned for at least 2 grafts
- Ability to comply with all study and follow-up procedures
- Signed informed consent to participate
- Normal flow in grafts as measured during surgery
- Left anterior descending artery grafted with internal thoracic artery
- No intraoperative decision for hybrid revascularization or endarterectomy performed
- No additional unplanned procedures during surgery
You will not qualify if you...
- Cardiogenic shock
- Recent acute coronary syndrome within 12 months
- Single vessel coronary artery bypass grafting
- Preoperative atrial fibrillation
- Dialysis treatment
- Low platelet count (thrombocytopenia)
- Anemia with hemoglobin less than 10 g/dL
- Severe liver failure (Child-Pugh classification >4)
- Active infections with HIV, HBV, HCV, or tuberculosis
- Active cancer or history of cancer within past 5 years
- Indication for dual antiplatelet therapy or oral anticoagulants prior to surgery
- Use of methotrexate at doses of 15 mg/week or more
- Contraindication to prasugrel or aspirin
- Planned additional cardiac or non-cardiac surgery within 12 months
- Non-cardiac conditions limiting life expectancy to less than 12 months
- History of bleeding complications with dual antiplatelet therapy
- History of intracranial or gastrointestinal bleeding
- Pregnancy or breastfeeding
- Lack of use of effective birth control
- Planned coronary endarterectomy
- Severe impaired kidney function (eGFR <40 mL/min/1.73 m2)
- Perioperative cardiogenic shock
- Death before randomization
- Myocardial infarction or stroke within 12-24 hours after surgery
- Postoperative complications increasing risk with dual antiplatelet therapy
- Atrial fibrillation or gastrointestinal bleeding before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
University Clinical Hospital in Bialystok
Bialystok, Poland
Not Yet Recruiting
2
Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz
Bydgoszcz, Poland
Not Yet Recruiting
3
Medical University of Gdansk
Gdansk, Poland
Not Yet Recruiting
4
Regional Specialist Hospital in Grudziadz
Grudziądz, Poland
Not Yet Recruiting
5
Upper-Silesian Heart Center
Katowice, Poland
Not Yet Recruiting
6
John Paul II Hospital
Krakow, Poland
Not Yet Recruiting
7
Medical University of Lodz
Lodz, Poland
Not Yet Recruiting
8
Zbigniew Religa Heart Center "Medinet"
Nowa Sól, Poland
Actively Recruiting
9
Provincial Specialist Hospital in Olsztyn
Olsztyn, Poland
Not Yet Recruiting
10
Institute of Medical Sciences in Opole
Opole, Poland
Not Yet Recruiting
11
J. Struś Hospital
Poznan, Poland
Not Yet Recruiting
12
Poznan University of Medical Sciences
Poznan, Poland
Not Yet Recruiting
13
Pomeranian Medical University
Szczecin, Poland
Not Yet Recruiting
14
Central Clinical Hospital of the Ministry of Interior and Administration
Warsaw, Poland
Not Yet Recruiting
15
Medicover Hospital
Warsaw, Poland
Not Yet Recruiting
16
Wroclaw Medical University
Wroclaw, Poland
Not Yet Recruiting
17
Zbigniew Religa Heart Center "Medinet"
Wroclaw, Poland
Actively Recruiting
18
Silesian Centre for Heart Diseases in Zabrze
Zabrze, Poland
Not Yet Recruiting
Research Team
A
Aleksandra Pawlik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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