E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atrial fibrillation and coronary artery disease |
Atriumfibrilleren en coronairlijden
|
|
E.1.1.1 | Medical condition in easily understood language |
Atrial fibrillation and coronary artery disease |
Atriumfibrilleren en vernauwde kransslagaders |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To compare bleeding risk of dual antiplatelet therapy compared to standard therapy (NOAC + P2Y12 inhibitor, aspirin in selected high-risk cases) during the first 30 days following PCI/ACS in patients with AF 2. To compare bleeding risk of dual antiplatelet therapy compared to standard therapy (NOAC + P2Y12 inhibitor, aspirin in selected high-risk cases) during the first 30 days following PCI/ACS in patients with AF |
Het risico op bloedingen en ischemische events onderzoeken met DAPT vergeleken met standaard therapie in de eerste 30 dagen na PCI/ACS in patiënten met atriumfibrilleren |
|
E.2.2 | Secondary objectives of the trial |
Assess net clinical benefit, quality of life, separate components of primary endpoints |
Beoordelen kwaliteit van leven, netto klinisch voordeel, losse componenten van de samengestelde primaire eindpunten |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. ≥18 years of age 2. Undergoing PCI or presenting with ACS with elevated cardiac markers (CK/CK-MB, troponin) 3. History of or newly diagnosed atrial fibrillation or flutter with a long-term (≥ 1 year) indication for OAC |
1. Boven 18 jaar oud 2. Na PCI of presentatie met acuut coronair syndroom met verhoogde hartenzymen 3. Atriumfibrilleren met lange termijn indicatie orale antistolling |
|
E.4 | Principal exclusion criteria |
1. Contra indication to edoxaban 2. <3 months after any stroke 3. <3 months after venous thrombo embolism 4. Mechanical heart valve prosthesis 5. Moderate to severe mitral valve stenosis 6. Intracardiac thrombus |
1. Contraindicatie voor edoxaban 2. <3 maanden na ischemisch of hemorrhagisch CVA 3. <3 maanden na veneuze tromboembolie 4. Mechanische hartklepprothese 5. Matig-ernstige mitralisklepstenose 6. Intracardiaal trombus |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary safety endpoint: major or clinically relevant non-major bleeding as defined by the ISTH Primary efficacy endpoint: a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis |
Primair eindpunt voor veiligheid: ISTH major + klinisch relevante non-major bloeding Primair eindpunt voor effectiviteit: samengesteld eindpunt van all-cause death, myocardinfarct, CVA, systemisch embolie, stent trombose |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at 30 days after randomization |
30 dagen na randomisatie |
|
E.5.2 | Secondary end point(s) |
Separate components of primary endpoints, net clinical benefit, quality of life |
Kwaliteit van leven, netto klinisch voordeel, losse componenten van de samengestelde primaire eindpunten |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At 30 days and 6 months |
Na 30 dagen en 6 maanden |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Guideline directed therapy compared to DAPT without NOAC during the first month after PCI/ACS |
Guideline directed therapy compared to DAPT without NOAC during the first month after PCI/ACS |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 25 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |