Optimal antiplatelet therapy in patients after coronary artery bypass grafting.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

24 Nov 2025 → ongoing

Decision date (initial)

2025-09-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Medical Research Agency, 69 Chmielna Street, 00-081 Warszawa

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response

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.

Secondary objectives 3

1. To investigate the effect of low-dose ASA plus prasugrel versus low-dose ASA and versus high-dose ASA and low-dose ASA versus high-dose ASA on the 12-month risk of ischemic and bleeding events and to assess quality of life at 6, 12 months and long-term after randomization following CABG procedure
2. To investigate the safety of low-dose ASA plus prasugrel vs low-dose ASA and vs high-dose ASA 12 weeks after randomization following CABG procedure.
3. To compare the effect of low-dose ASA 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.

Conditions and MedDRA coding

Primary isolated CABG patients with stable coronary artery disease (chronic coronary syndrome) planned for at least 2 grafts.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age >18 years
2. 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.
3. Ability to comply with all study procedures and follow-up procedures
4. Signed Informed Consent to participate in the study.
5. 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
6. 2. Left anterior descending artery grafted with internal thoracic artery
7. 3. No intraoperative decision for hybrid revascularization due to incomplete revascularization (Percutaneous coronary intervention (PCI) of the ungrafted vessel)
8. 4. No endarterectomy of the grafted vessel performed
9. 5. Patient did not have any additional unplanned procedure (Ex. LAAC, Ablation, valve intervention, aortic intervention)

Exclusion criteria 30

1. Baseline (preoperative) exclusion criteria: 1. Cardiogenic shock
2. Patients with recent acute coronary syndrome (ACS) (<12 months)
3. Single vessel CABG
4. Patients with preoperative atrial fibrillation
5. Dialysis
6. Thrombocytopenia (platelet count < 100 000 platelets/ul)
7. Anemia (Hemoglobin level < 10 g/dL)
8. Severe liver failure Child-Pugh classification >4
9. Known, active infections with HIV, HBV, HCV, tuberculosis
10. Active malignant disease or history of malignancy within the past 5 years
11. Indication for DAPT (e.g. recent PCI or ACS or recent stents of peripheral arteries)
12. 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).
24. Postoperative and prior randomization exclusion criteria: 1. Perioperative cardiogenic shock
25. 2. Intraoperative death or death prior randomization
26. 3. Myocardial infarction within 12-24 hours following CABG or prior randomization
27. 4. Ischemic or hemorrhagic stroke within 12-24 hours following CABG or prior randomization
28. 5. Any postoperative complication that may increase patients’ risk with DAPT
29. 6. Atrial Fibrillation prior randomization
30. 7. Gastro-intestinal bleeding prior randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The assessment of the proportion of failed grafts is defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure in patients with DAPT with prasugrel (10mg/day) plus ASA (75mg/day) vs high-dose ASA (300mg/d) and DAPT vs low-dose ASA (75mg/day)

Secondary endpoints 10

1. The assessment of the proportion of failed grafts defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG procedure, in patients receiving high- (300mg/d) vs low-dose ASA (75mg/day).
2. A safety and efficacy assessment of use of the investigational products, based on the frequency of reported adverse events during the first 6 and 12 and long term follow up months after randomization.
3. a) All-cause mortality at 12 months in the three groups
4. b) Incidence of myocardial infarction in the three groups
5. c) Incidence of stroke in the three groups
6. d) Incidence of repeat revascularization in the three groups
7. e) Incidence of MACCE (composite mortality, myocardial infarction, stroke and repeat revascularization) at 12 months and beyond 12 months in the three groups
8. f) Safety of treatment in terms of the incidence of bleeding within 12 months according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 in three groups.
9. g) Quality of life questionnaires evaluated using SAQ 7 and SF 12.
10. Safety of short-term use of the investigational product - assessment until 12 weeks from randomization visit based on the frequency of reported adverse events (AE, AESI, SAE) – type, grading, relationship to prasugrel /ASA.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.

Sponsor organisation

Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.

Address

Ul. Henryka Michala Kamienskiego 73a

City

Wroclaw

Postcode

51-124

Country

Poland

Scientific contact point

Organisation

Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.

Contact name

Lead Principal Investigator

Public contact point

Organisation

Dolnoslaskie Centrum Chorob Serca Im. Prof. Zbigniewa Religi Medinet Sp. z o.o.

Contact name

Lead Principal Investigator

Third parties 2

Locations

1 EU/EEA country · 18 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications