Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 06/30/2020 |
| Primero enviado: | 02/03/2020 |
| Inscripción estimada enviada: | 02/05/2020 |
| Publicado por primera vez: | 02/09/2020 |
| Última actualización enviada: | 07/06/2020 |
| Última actualización publicada: | 07/07/2020 |
| Fecha de inicio real del estudio: | 05/14/2020 |
| Fecha estimada de finalización primaria: | 01/31/2024 |
| Fecha estimada de finalización del estudio: | 03/31/2024 |
Condición o enfermedad
Intervención / tratamiento
Drug: Anticoagulation
Drug: No anticoagulation
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Anticoagulation Patients in the anticoagulation group will receive rivaroxaban 15 mg twice daily for the first 21 days, followed by 20 mg once daily for an overall treatment duration of 90 days. | Drug: Anticoagulation Anticoagulation |
| Placebo Comparator: No anticoagulation Patients in the group without anticoagulation will receive placebo twice daily for the first 21 days, followed by one tablet daily for an overall treatment duration of 90 days. | Drug: No anticoagulation Study drug without active agent |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. Informed Consent as documented by signature 2. Age ≥18 years 3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE Exclusion Criteria: 1. Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above) 2. Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months 3. ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor) 4. Clinical instability (systolic blood pressure <100 mm Hg or arterial Oxygen saturation <92% at ambient air) at the time of presentation 5. Active bleeding or at high risk of bleeding 6. Severe renal failure (creatinine clearance <30ml/min) 7. Severe liver insufficiency (Child-Pugh B or C) 8. Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers 9. Known hypersensitivity to rivaroxaban 10. Need for therapeutic anticoagulation for another reason 11. Therapeutic anticoagulation for >72 hours for any reason at the time of screening 12. Hospitalized for >72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE) 13. Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential) 14. Lack of safe contraception in women of childbearing potential 15. Refusal or inability to provide informed consent 16. Prior enrolment in this trial |
Salir
Medidas de resultado primarias
1. Recurrent venous thromboembolism [Within 90 days of randomization]
Medidas de resultado secundarias
1. Clinically significant bleeding [Within 90 days of randomization]
2. All-cause mortality [Within 90 days of randomization]
Otras medidas de resultado
1. Health-related quality of life [Within 90 days of randomization]
2. Functional status [Within 90 days of randomization]
3. Initial length of stay (LOS) [Within 90 days of randomization]
4. Subsequent overall hospitalizations [Within 90 days of randomization]
5. Emergency departments and physician outpatient visits [Within 90 days of randomization]
6. Return to work or usual activities [Within 90 days of randomization]
