BridgeMD
Compares treatment options for Chronic Coronary Syndrome
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)
ClinicalTrials.gov ID: NCT07195149
What this study is testing
What is High-Dose Aspirin 300 mg?
High-Dose Aspirin 300 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic coronary syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A. Baseline (preoperative) 1. Age \>18 years
- Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts. Coronary artery disease...
- Ability to comply with all study procedures and follow-up procedures
- Signed Informed Consent to participate in the study. B. Operative
- Intraoperative graft evaluation using transit time flow measurement in all grafts, normal flow in any graft is defined as mean graft flow \> 15...
You likely can't join if
- A. Baseline (preoperative) exclusion criteria:
- Cardiogenic shock
- Patients with recent acute coronary syndrome (ACS) (\<12 months)
- Single vessel CABG
- Patients with preoperative atrial fibrillation
- Dialysis
See the full eligibility criteria
- A. Baseline (preoperative) 1. 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...
- Ability to comply with all study procedures and follow-up procedures
- Signed Informed Consent to participate in the study. B. Operative
- 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)
- A. Baseline (preoperative) exclusion criteria:
- Cardiogenic shock
- Patients with recent acute coronary syndrome (ACS) (\<12 months)
- Single vessel CABG
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bialystok, Poland
- Bydgoszcz, Poland
- Gdansk, Poland
- Grudziądz, Poland
- Katowice, Poland
- Krakow, Poland
- Lodz, Poland
- Nowa Sól, Poland
- Olsztyn, Poland
- Opole, Poland
- Poznan, Poland
- Szczecin, Poland
- Warsaw, Poland
- Wroclaw, Poland
- Zabrze, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bialystok, Poland; Bydgoszcz, Poland; Gdansk, Poland; Grudziądz, Poland; Katowice, Poland; Krakow, Poland and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.