E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute coronary syndrome in patients with known or new atrial fibrillation with indication for oral anticoagulants |
Acuut coronair syndroom in patienten met nieuw of bekend atriumfibrilleren met indicatie voor orale anticoagulantia |
|
E.1.1.1 | Medical condition in easily understood language |
Heart attack in patients with known or new atrial fibrillation |
Hartaanval in patienten met bekend of nieuw boezemfibrilleren |
|
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 investigate the efficacy of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome.
2. To investigate the safety of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome. |
1. De effectiviteit (trombose) van duale therapie onderzoeken in vergelijking met triple therapie in patiënten met acuut coronair syndroom en atriumfibrilleren
2. De veiligheid (bloedingen) van duale therapie onderzoeken in vergelijking met triple therapie in patiënten met acuut coronair syndroom en 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 |
Over 18 years of age
Acute coronary syndrome with elevated cardiac enzymes
Atrial fibrillation with long-term indication for oral anticoagulation |
Boven 18 jaar oud
Acuut coronair syndroom met verhoogde hartenzymen
Atriumfibrilleren met lange termijn indicatie orale antistolling |
|
E.4 | Principal exclusion criteria |
Severe bleeding in past 3 months
Known coagulopathy
Contra-indications for intended medication (NOAC, P2Y12-remmer, ASA)
eGFR < 15 min/kg/1.73m2 |
Ernstige bloeding in afgelopen 3 maanden
Bekende stollingsstoornis
Contra-indicatie voor voorgenomen medicatie (NOAC, P2Y12-remmer, ASA)
eGFR < 15 min/kg/1.73m2 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: composed endpoint of all-cause death, MI, stroke, systemic embolism, stent thrombosis.
Primary safety endpoint: ISTH major + clinically relevant non-major bleeding. |
Primair eindpunt voor effectiviteit: samengesteld eindpunt van all-cause death, myocardinfarct, CVA, systemisch embolie, stent trombose
Primair eindpunt voor veiligheid: ISTH major + klinisch relevante non-major bloeding |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 30 days, 6 months and 12 months |
Na 30 dagen, 6 maanden en 12 maanden |
|
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, 6 months and 12 months |
Na 30 dagen, 6 maanden en 12 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 |
Triple therapie (NOAC + P2Y12 inhibitor + ascal) vergeleken met duale therapie zonder ascal |
Triple therapy (NOAC + P2Y12 inhibitor + ASA) as standard is compared to dual therapy omitting ASA |
|
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |