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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521892-30-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Medical Research Agency, Poland | OTHER_GOV |
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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.
This is a multicenter, randomized trial evaluating the effect of low-dose aspirin plus prasugrel versus low-dose ASA and versus high-dose ASA for three months, followed by low-dose ASA alone, on graft failure at 12 months in patients with stable coronary artery disease (chronic coronary syndrome) following a coronary artery bypass grafting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prasugrel 10 mg + Low Dose Aspirin 75 mg | Experimental |
| |
| Low-Dose Aspirin 75 mg | Active Comparator |
| |
| High-Dose Aspirin 300 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Dose Aspirin 300 mg | Drug | High-dose Aspirin 300 mg once daily taken orally for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of graft failure: DAPT vs Low-Dose Aspirin and DAPT vs High-Dose Aspirin | Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) versus high-dose aspirin (300mg/day) and in patients with DAPT (prasugrel 10mg/day + low dose aspirin 75mg/day) vs low-dose aspirin (75mg/day) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary outcome: Incidence of graft failure: High-Dose Aspirin vs Low-Dose Aspirin | Incidence of graft failure defined according to Fitzgibbon classification (Fitzgibbon Class B + O) 12 months after the randomization following CABG in patients with high-dose aspirin (300mg/day) vs low-dose aspirin (75mg/day) | 12 months |
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Inclusion Criteria:
A. Baseline (preoperative) inclusion criteria
B. Operative inclusion criteria:
Exclusion Criteria:
A. Baseline (preoperative) exclusion criteria:
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).
B. Postoperative and prior randomization exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aleksandra Pawlik | Contact | +48 71 320 94 50 | badaniakliniczne@medinet.pl |
| Name | Affiliation | Role |
|---|---|---|
| Sleiman Sebastian Aboul-Hassan, MD, PhD | Zbigniew Religa Heart Center "Medinet" | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinical Hospital in Bialystok | Not yet recruiting | Bialystok | Poland |
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| DAPT (Low-Dose Aspirin 75 mg + Prasugrel 10 mg) | Drug | Drug: Prasugrel 10 mg Prasugrel 10 mg once daily taken orally for 3 months Drug: Low-Dose Aspirin 75 mg once daily taken orally |
|
| Low-Dose Aspirin 75 mg | Drug | Low-Dose Aspirin 75 mg once daily taken orally |
|
| investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of ischemic events after CABG |
Major adverse cardiac and cerebral events (MACCE) is a composite endpoint to be compared between groups defined as composite of:
|
| 12 months |
| Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 12-month risk of bleeding events after CABG | Incidence of bleeding within 12 months after randomization following CABG procedure according to the Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 | 12 months |
| Investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on quality of life at 6 and 12 months after CABG. | Quality of life will be assessed using quality of life questionnaires at baseline, 6 and 12 months after randomization following CABG procedure and will be evaluated using The Seattle Angina Questionnaire - 7 (SAQ-7) and Short-form-12 health survey questionnaire (SF-12) | 12 months |
| investigatigating the effect of DAPT versus low-dose aspirin, DAPT versus high-dose aspirin and low-dose aspirin versus high-dose aspirin on the 60-month risk of ischemic events after CABG | Major adverse cardiac and cerebral events (MACCE) is a composite endpoint to be compared between groups defined as composite of:
| 60 months |
| Nicolaus Copernicus University Ludwik Rydygier Collegium Medicum in Bydgoszcz | Not yet recruiting | Bydgoszcz | Poland |
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| Medical University of Gdansk | Not yet recruiting | Gdansk | Poland |
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| Regional Specialist Hospital in Grudziadz | Not yet recruiting | Grudziądz | Poland |
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| Upper-Silesian Heart Center | Not yet recruiting | Katowice | Poland |
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| John Paul II Hospital | Not yet recruiting | Krakow | Poland |
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| Medical University of Lodz | Not yet recruiting | Lodz | Poland |
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| Zbigniew Religa Heart Center "Medinet" | Recruiting | Nowa Sól | Poland |
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| Provincial Specialist Hospital in Olsztyn | Not yet recruiting | Olsztyn | Poland |
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| Institute of Medical Sciences in Opole | Not yet recruiting | Opole | Poland |
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| J. Struś Hospital | Not yet recruiting | Poznan | Poland |
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| Poznan University of Medical Sciences | Not yet recruiting | Poznan | Poland |
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| Pomeranian Medical University | Not yet recruiting | Szczecin | Poland |
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| Central Clinical Hospital of the Ministry of Interior and Administration | Active, not recruiting | Warsaw | Poland |
| Medicover Hospital | Recruiting | Warsaw | Poland |
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| Wroclaw Medical University | Not yet recruiting | Wroclaw | Poland |
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| Zbigniew Religa Heart Center "Medinet" | Recruiting | Wroclaw | Poland |
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| Silesian Centre for Heart Diseases in Zabrze | Active, not recruiting | Zabrze | Poland |
| ID | Term |
|---|---|
| D001241 | Aspirin |
| C028145 | 2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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