Status:
RECRUITING
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
Lead Sponsor:
Drahomir Aujesky
Collaborating Sponsors:
University of Bern
Schweizerischer Nationalfonds
Conditions:
Pulmonary Embolism
Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated ...
Eligibility Criteria
Inclusion Criteria:
- Informed Consent as documented by signature
- Age ≥18 years
- Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Exclusion Criteria:
- Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
- Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
- ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
- Clinical instability (systolic blood pressure <100 mm Hg or arterial Oxygen saturation <92% at ambient air) at the time of presentation
- Active bleeding or at high risk of bleeding
- Severe renal failure (creatinine clearance <30ml/min)
- Severe liver insufficiency (Child-Pugh B or C)
- Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
- Known hypersensitivity to rivaroxaban
- Need for therapeutic anticoagulation for another reason
- Therapeutic anticoagulation for >72 hours for any reason at the time of screening
- Hospitalized for >72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
- Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
- Lack of safe contraception in women of childbearing potential
- Refusal or inability to provide informed consent
- Prior enrolment in this trial
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT04263038
Start Date
May 15 2020
End Date
May 1 2026
Last Update
May 30 2025
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre hospitalier universitaire de Liege
Liège, Belgium
2
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
3
The Ottawa Hospital
Ottawa, Canada
4
Hôpital Bicêtre - APHP
Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France, 94270