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Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
Sponsor: Drahomir Aujesky
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 SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.
Official title: Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
276
Start Date
2020-05-15
Completion Date
2026-05
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Rivaroxaban
Anticoagulation
Placebo
Study drug without active agent
Locations (39)
Centre hospitalier universitaire de Liege
Liège, Belgium
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
The Ottawa Hospital
Ottawa, Canada
Hôpital Bicêtre - APHP
Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France
Centre Hospitalier Regional Et Universitaire De Brest
Brest, France
CHU Gabriel-Montpied
Clermont-Ferrand, France
Centre Hospitalier Universitaire De Dijon
Dijon, France
Hospital Edouard Herriot
Lyon, France
CHU De Rouen
Rouen, France
CHU ST Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France
Albert Schweitzer Ziekenhuis Dordrecht
Dordrecht, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Universitair Medisch Centrum
Rotterdam, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
Isala Klinieken Zwolle
Zwolle, Netherlands
Cantonal Hospital of Liestal
Liestal, Basel, Switzerland
Cantonal Hospital of Aarau
Aarau, Canton of Aargau, Switzerland
University Hospital Inselspital
Bern, Canton of Bern, Switzerland
Hospital of Bienne
Biel/Bienne, Canton of Bern, Switzerland
Cantonal Hospital of Fribourg
Fribourg, Canton of Fribourg, Switzerland
Cantonal Hospital of Lucerne
Lucerne, Canton of Lucerne, Switzerland
Cantonal Hospital of Olten
Olten, Canton of Solothurn, Switzerland
Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
University Hospital of Lausanne
Lausanne, Canton of Vaud, Switzerland
Hospital of Nyon
Nyon, Canton of Vaud, Switzerland
Cantonal Hospital of Winterthur
Winterthur, Canton of Zurich, Switzerland
Triemli Hospital
Zurich, Canton of Zurich, Switzerland
University Hospital Zürich
Zurich, Canton of Zurich, Switzerland
Cantonal Hospital of Frauenfeld
Frauenfeld, Thurgau, Switzerland
Hospital of Sion
Sion, Valais, Switzerland
Cantonal Hospital of Uri
Altdorf, Switzerland
Cantonal Hospital of Baden
Baden, Switzerland
University Hospital of Basel
Basel, Switzerland
Tiefenau Hospital
Bern, Switzerland
Regional Hospital of Emmental
Burgdorf, Switzerland
Hospital of Delémont
Delémont, Switzerland
Geneva University Hospital
Geneva, Switzerland
Hospital of Neuchâtel
Neuchâtel, Switzerland