Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial
Date de révision : 04/05/2026
50 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 08/07/2024
Date de fin de recrutement : 30/03/2026
Critères :
Critères d'inclusion :
- 1) Informed Consent as documented by signature 2) Age ≥18 years 3) Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Critères d'exclusion :
- 1) Presence of leg 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; or presence of metastatic cancer 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 SSPE (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
Lieux et contacts
Informations pratiques pour participer à cet essai.
Sites des essais
Adresse
CHU St Etienne - Hôpital Nord
42270 Saint-Priest-en-Jarez France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".