Actively Recruiting
Comparing High- and Low-Dose Aspirin with Dual Antiplatelet Therapy Using Prasugrel and Aspirin for Three Months 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 2026-06-05
1703
Participants Needed
18
Research Sites
30 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
Researchers are evaluating the effects of different aspirin doses combined with prasugrel on patients with stable coronary artery disease undergoing coronary artery bypass grafting (CABG). This Phase 3 randomized trial compares dual antiplatelet therapy (prasugrel plus low-dose aspirin) against low-dose aspirin alone and high-dose aspirin alone over three months, aiming to understand their impact on graft failure and other heart-related events. Participants receive either prasugrel 10 mg plus low-dose aspirin 75 mg daily, low-dose aspirin 75 mg alone, or high-dose aspirin 300 mg alone for three months. After this period, all participants continue with low-dose aspirin alone. The study includes detailed graft evaluations during surgery to ensure proper blood flow and excludes patients with certain heart complications or additional surgeries. During the study, participants will be monitored for graft failure at 12 months, with assessments of ischemic and bleeding events, quality of life at 6 and 12 months, and long-term ischemic risk up to 60 months. Researchers will track adherence to medications and perform follow-up visits to collect data on heart health and safety. The total involvement spans several years to evaluate both short- and long-term outcomes after CABG.
CONDITIONS
Brief 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
- Scheduled for primary isolated coronary artery bypass grafting with stable coronary artery disease and at least 2 grafts planned
- Ability to follow all study and follow-up procedures
- Signed informed consent to participate
- Intraoperative graft evaluation showing normal blood flow
- Grafting of the left anterior descending artery with internal thoracic artery
- No hybrid revascularization planned due to incomplete revascularization
- No endarterectomy performed on grafted vessels
- No additional unplanned cardiac or non-cardiac procedures during surgery
You will not qualify if you...
- Cardiogenic shock before surgery
- Recent acute coronary syndrome within the past 12 months
- Single vessel coronary artery bypass grafting
- Preoperative atrial fibrillation
- Dialysis treatment
- Low platelet count (below 100,000 platelets/uL)
- Anemia with hemoglobin less than 10 g/dL
- Severe liver failure (Child-Pugh score over 4)
- Known active infections such as HIV, HBV, HCV, or tuberculosis
- Active cancer or history of cancer within 5 years
- Need for dual antiplatelet therapy due to recent PCI, acute coronary syndrome, or recent stents
- Requirement for oral anticoagulant therapy
- Use of methotrexate at doses of 15 mg/week or more
- Contraindications for prasugrel or aspirin
- Planned additional cardiac or non-cardiac surgery within 12 months
- Other serious medical 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
- Not using effective birth control methods
- Planned coronary endarterectomy
- Severe kidney impairment (eGFR less than 40 mL/min/1.73 m2)
- Postoperative complications increasing risk from dual antiplatelet therapy
- Intraoperative or early postoperative death
- Myocardial infarction or stroke within 12-24 hours after surgery or before randomization
- New atrial fibrillation or gastrointestinal bleeding before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 3 months
Participants receive one of three drug regimens: high-dose aspirin, dual antiplatelet therapy with low-dose aspirin and prasugrel, or low-dose aspirin alone for three months following coronary artery bypass grafting.
Visits occur during the 3 months of treatment
Duration - Up to 9 months after treatment (total 12 months from treatment start)
Participants are monitored for outcomes including graft failure and ischemic or bleeding events for up to 12 months after treatment.
Periodic visits during follow-up up to 12 months
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
Active, Not Recruiting
15
Medicover Hospital
Warsaw, Poland
Actively 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
Active, Not Recruiting
Research Team
A
Aleksandra Pawlik
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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