Actively Recruiting
Led by Drahomir Aujesky · Updated on 2026-05-22
276
Participants Needed
40
Research Sites
N/A
Total Duration
D
Drahomir Aujesky
Lead Sponsor
U
University of Bern
Collaborating Sponsor
Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism (SSPE), a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.
CONDITIONS
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants receive anticoagulation or placebo treatment for isolated subsegmental pulmonary embolism.
Regular visits during treatment as per study schedule
Total: 40 locations
1
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
Actively Recruiting
2
Centre hospitalier universitaire de Liege
Liège, Belgium
Actively Recruiting
3
The Ottawa Hospital
Ottawa, Canada
Actively Recruiting
4
Hôpital Bicêtre - APHP
Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
5
Centre Hospitalier Regional Et Universitaire De Brest
Brest, France
Actively Recruiting
6
CHU Gabriel-Montpied
Clermont-Ferrand, France
Actively Recruiting
7
Centre Hospitalier Universitaire De Dijon
Dijon, France
Actively Recruiting
8
Hospital Edouard Herriot
Lyon, France
Actively Recruiting
9
Hôpitaux universitaires de Marseille Timone AP-HM
Marseille, France
Actively Recruiting
10
CHU De Rouen
Rouen, France
Actively Recruiting
11
CHU ST Etienne - Hôpital Nord
Saint-Priest-en-Jarez, France
Actively Recruiting
12
Albert Schweitzer Ziekenhuis Dordrecht
Dordrecht, Netherlands
Actively Recruiting
13
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
14
Leiden University Medical Center
Leiden, Netherlands
Actively Recruiting
15
Erasmus Universitair Medisch Centrum
Rotterdam, Netherlands
Withdrawn
16
Haaglanden Medisch Centrum
The Hague, Netherlands
Withdrawn
17
Isala Klinieken Zwolle
Zwolle, Netherlands
Actively Recruiting
18
Cantonal Hospital of Liestal
Liestal, Basel, Switzerland
Actively Recruiting
19
Cantonal Hospital of Aarau
Aarau, Canton of Aargau, Switzerland
Actively Recruiting
20
University Hospital Inselspital
Bern, Canton of Bern, Switzerland, 3010
Actively Recruiting
21
Hospital of Bienne
Biel/Bienne, Canton of Bern, Switzerland
Actively Recruiting
22
Cantonal Hospital of Fribourg
Fribourg, Canton of Fribourg, Switzerland
Withdrawn
23
Cantonal Hospital of Lucerne
Lucerne, Canton of Lucerne, Switzerland
Withdrawn
24
Cantonal Hospital of Olten
Olten, Canton of Solothurn, Switzerland
Withdrawn
25
Cantonal Hospital of St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Actively Recruiting
26
University Hospital of Lausanne
Lausanne, Canton of Vaud, Switzerland
Actively Recruiting
27
Hospital of Nyon
Nyon, Canton of Vaud, Switzerland
Withdrawn
28
Cantonal Hospital of Winterthur
Winterthur, Canton of Zurich, Switzerland
Actively Recruiting
29
Triemli Hospital
Zurich, Canton of Zurich, Switzerland
Actively Recruiting
30
University Hospital Zürich
Zurich, Canton of Zurich, Switzerland
Withdrawn
31
Cantonal Hospital of Frauenfeld
Frauenfeld, Thurgau, Switzerland
Actively Recruiting
32
Hospital of Sion
Sion, Valais, Switzerland
Withdrawn
33
Cantonal Hospital of Uri
Altdorf, Switzerland
Withdrawn
34
Cantonal Hospital of Baden
Baden, Switzerland
Actively Recruiting
35
University Hospital of Basel
Basel, Switzerland
Actively Recruiting
36
Tiefenau Hospital
Bern, Switzerland
Completed
37
Regional Hospital of Emmental
Burgdorf, Switzerland
Actively Recruiting
38
Hospital of Delémont
Delémont, Switzerland
Terminated
39
Geneva University Hospital
Geneva, Switzerland
Actively Recruiting
40
Hospital of Neuchâtel
Neuchâtel, Switzerland
Actively Recruiting
D
Drahomir Aujesky, Prof. MD MSc
T
Tobias Tritschler, Dr. MD MSc
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Christine Baumgartner, Frederikus A Klok, Marc Carrier...
https://pubmed.ncbi.nlm.nih.gov/33444199