| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Perioperative atrial fibrillation after noncardiac surgery |
| Fibrilación auricular perioperatoria tras cirugía no cardiaca |
|
| E.1.1.1 | Medical condition in easily understood language |
| Fast, irregular heartbeat after noncardiac surgery |
| Latido cardíaco rápido e irregular después de una cirugía no cardíaca |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 22.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042244 |
| E.1.2 | Term | Stroke |
| E.1.2 | System Organ Class | 100000004852 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10005103 |
| E.1.2 | Term | Bleeding |
| E.1.2 | System Organ Class | 100000004866 |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10003663 |
| E.1.2 | Term | Atrial flutter/ fibrillation |
| E.1.2 | System Organ Class | 100000004849 |
|
| 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 |
| The primary objective of this pilot study is to assess the feasibility of a randomized controlled trial of non-vitamin K oral anticoagulants (NOACs) versus no oral anticoagulation in patients with perioperative atrial fibrillation (AF) after noncardiac surgery and additional stroke risk factors. |
| El objetivo principal de este estudio piloto es evaluar la viabilidad de un ensayo controlado aleatorizado de anticoagulantes orales sin vitamina K (NOAC) versus ninguna anticoagulación oral en pacientes con fibrilación auricular (FA) perioperatoria después de una cirugía no cardíaca y factores de riesgo de accidente cerebrovascular adicionales. |
|
| E.2.2 | Secondary objectives of the trial |
The secondary trial objectives are to collect preliminary information on the effects of NOACs on the incidence of:
1. non-hemorrhagic stroke or systemic arterial embolism;
2. all-cause mortality;
3. vascular mortality;
4. myocardial infarction;
5. symptomatic venous thromboembolism;
6. hospitalization for congestive heart failure;
7. cardiac revascularization procedure;
8. peripheral arterial thrombosis;
9. amputation; and
10. all-cause hospitalizations. |
Los objetivos del ensayo secundario son recopilar información preliminar sobre los efectos de los NOAC en la incidencia de:
1. accidente cerebrovascular no hemorrágico o embolia arterial sistémica;
2. mortalidad por cualquier causa;
3. mortalidad vascular;
4. infarto de miocardio;
5. tromboembolismo venoso sintomático;
6. hospitalización por insuficiencia cardíaca congestiva;
7. procedimiento de revascularización cardíaca;
8. trombosis arterial periférica;
9. amputación; y
10. hospitalizaciones por cualquier causa. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Patients are eligible if they fulfill all of the following criteria:
1. have had noncardiac surgery with at least an overnight hospital admission after surgery in the last 35 days;
2. have had ≥ one episode of clinically significant perioperative AF;
3. are in sinus rhythm at the time of randomization;
4. meet any of the following high-risk criteria; and
o age ≥ 55 years, and having either known cardiovascular disease, recent major vascular surgery, or a CHA2DS2VASc score ≥ 3;
o age ≥ 65 and a CHA2DS2VASc score ≥ 2; or
o age ≥ 75 years.
5. provide written informed consent to participate |
Los pacientes son elegibles si cumplen con todos los siguientes criterios:
1. haber tenido una cirugía no cardíaca con un ingreso hospitalario de al menos una noche después de la cirugía en los últimos 35 días;
2. haber tenido ≥ 1 episodio de FA perioperatoria clínicamente significativa;
3. estar en ritmo sinusal en el momento de la aleatorización;
4. cumplir con cualquiera de los siguientes criterios de alto riesgo; y
o edad ≥ 55 años, y tener enfermedad cardiovascular conocida, cirugía vascular mayor reciente o una puntuación CHA2DS2VASc ≥ 3;
o edad ≥ 65 y una puntuación CHA2DS2VASc ≥ 2; o
o edad ≥ 75 años.
5. proporcionar consentimiento informado por escrito para participar |
|
| E.4 | Principal exclusion criteria |
Patients are excluded if they meet any of the following criteria:
1. have a history of documented AF prior to noncardiac surgery; a history of subclinical AF only (i.e., AF episodes only documented by pacemakers or similar devices) or a previous history of perioperative AF only (after cardiac or noncardiac surgery) are not exclusion criteria;
2. need for long-term systemic anticoagulation (e.g., pre-existing AF, mechanical heart valve);
3. have an ongoing need for long-term dual antiplatelet treatment;
4. have a contraindication to oral anticoagulation;
5. have severe renal insufficiency (eGFR < 30 ml/min);
6. have had an acute stroke in the past three months;
6. have had cardiac surgery in the past three months;
7. have a history of intracranial, intraocular, or spinal bleeding;
8. have hemorrhagic disorder or bleeding diathesis;
8. are expected to be non-compliant with follow-up and/or study medications;
9. have a known life expectancy less than one year due to concomitant disease;
10. are women who are pregnant, breastfeeding, or of childbearing potential; or
11. were previously enrolled in the trial. |
Se excluirán los pacientes si cumplen alguno de los siguientes criterios:
1. tener antecedentes de FA documentada antes de la cirugía no cardíaca; tener solamente historia de FA subclínica (es decir, episodios de FA solo documentados por marcapasos o dispositivos similares) o tener solamente historial previa de FA perioperatoria (después de cirugía cardíaca o no cardíaca) no son criterios de exclusión;
2. necesidad de anticoagulación sistémica a largo plazo (p. Ej., FA preexistente, válvula cardíaca mecánica);
3. tienen una necesidad continua de un tratamiento antiagregante plaquetario dual a largo plazo;
4. tienen una contraindicación para la anticoagulación oral;
5. tienen insuficiencia renal grave (eGFR <30 ml / min);
6. han tenido un accidente cerebrovascular agudo en los últimos tres meses;
6. se han sometido a una cirugía cardíaca en los últimos tres meses;
7. tienen antecedentes de hemorragia intracraneal, intraocular o espinal;
8. tienen un trastorno hemorrágico o diátesis hemorrágica;
8. se espera que no cumplan con los medicamentos de seguimiento y / o del estudio;
9. tienen una esperanza de vida conocida de menos de un año debido a una enfermedad concomitante;
10. son mujeres embarazadas, en período de lactancia o en edad fértil; o
11. haber participado previamente en el ensayo. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
1. Ability to recruit 100 patients at an average recruitment rate of one patient per centre per month
2. Ability to achieve complete follow-up on 90% or more of the patients
3. Ability to determine the resource requirements to achieve our recruitment and follow-up goals
4. Ability to determine the feasibility of administering oral anticoagulation |
1. Capacidad para reclutar 100 pacientes, con una tasa promedio de reclutamiento de un paciente por centro y por mes
2. Capacidad para lograr un seguimiento completo en el 90% o más de los pacientes
3. Capacidad para determinar los recursos necesarios para lograr nuestros objetivos de reclutamiento y seguimiento
4. Capacidad para determinar la viabilidad de administrar anticoagulación oral. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| When the last patient randomized has been followed for three months |
| Cuando el último paciente aleatorizado compleratá el seguimiento durante tres meses. |
|
| E.5.2 | Secondary end point(s) |
1. Non-hemorrhagic stroke or systemic arterial embolism
2. All-cause mortality
3. Vascular mortality
4. Myocardial infarction
5. Symptomatic venous thromboembolism
6. Hospitalization for congestive heart failure
7. Cardiac revascularization procedure
8. Peripheral arterial thrombosis
9. Amputation
10. All-cause hospitalizations |
1. Accidente cerebrovascular no hemorrágico o embolia arterial sistémica
2. Mortalidad por cualquier causa
3. Mortalidad vascular
4. Infarto de miocardio
5. Tromboembolismo venoso sintomático
6. Hospitalización por insuficiencia cardíaca congestiva
7. Procedimiento de revascularización cardíaca
8. Trombosis arterial periférica
9. Amputación
10. Hospitalizaciones por todas las causas |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| When the last patient randomized has been followed for three months |
| Cuando el último paciente aleatorizado compleratá el seguimiento durante tres meses. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| 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 | Yes |
| E.6.13.1 | Other scope of the trial description |
| Assess the feasibility of a randomized controlled trial of NOACs versus no oral anticoagulation |
| Evaluar la viabilidad de un ensayo controlado aleatorizado con NOAC versus ninguna anticoagulación oral |
|
| 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 | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| Prospective, randomized, open-label clinical trial with blinded outcome assessment (PROBE design) |
|
| 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 |
| Sin anticoagulación oral |
| No oral anticoagulation |
|
| 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
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 2 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| 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
|
| When the last patient randomized has been followed for three months |
| Cuando el último paciente aleatorizado compleratá el seguimiento durante tres meses. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
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