Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
NCT ID: NCT04263038
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
276 participants
INTERVENTIONAL
2020-05-15
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Rivaroxaban
Anticoagulation
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.
Placebo
Study drug without active agent
Interventions
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Rivaroxaban
Anticoagulation
Placebo
Study drug without active agent
Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years
3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University of Bern
OTHER
Schweizerischer Nationalfonds
OTHER
Leiden University Medical Center
OTHER
The Ottawa Hospital
OTHER
Bayer
INDUSTRY
Drahomir Aujesky
OTHER
Responsible Party
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Drahomir Aujesky
Prof. Dr., MD, MSc
Principal Investigators
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Drahomir Aujesky, Prof. MD MSc
Role: STUDY_DIRECTOR
Inselspital, Bern University Hospital, University of Bern
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Raphaelle Lopez Iglesias, MD
Role: primary
Andrea Penaloza Baeza, Prof., MD
Role: primary
Marc Carrier, Prof. MD MSc
Role: primary
Francis Couturaud, Prof. MD
Role: primary
Jeannot Schmidt, Prof., MD
Role: primary
Nicolas Falvo, MD
Role: primary
Judith Catella, MD
Role: primary
Sébastien Miranda, MD
Role: primary
Laurent Bertoletti, Prof., MD
Role: primary
P.E. Westerweel, MD
Role: primary
H.P.A.A. van Veen, MD
Role: primary
F. A. Klok, Prof. MD PhD
Role: primary
M. Kruip, MD
Role: primary
M. F. Boosma, MD
Role: primary
Jörg Leuppi, Prof. MD PhD
Role: primary
Philippe Schütz, Prof. MD MPH
Role: primary
Drahomir Aujesky, Prof. MD MSc
Role: primary
Daniel Genné, Prof. MD
Role: primary
Julien Vaucher, Prof. MD
Role: primary
Claudio S. Rüegg, MD
Role: primary
Marie Méan, MD MER
Role: primary
Bettina Portocarrero, MD
Role: primary
Lars Huber, PD MD
Role: primary
Ksenija Slankamenac, PD, MD, PhD
Role: primary
Andreas Kistler, PD MD
Role: primary
Maria Wertli, Prof. MD
Role: primary
Roland Bingisser, Prof. MD
Role: primary
Robert Escher, PD Dr. MD
Role: primary
Hervé Duplain, PD Dr. MD
Role: primary
Marc Righini, Prof. MD
Role: primary
Jacques Donzé, Prof. MD MSc
Role: primary
References
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Baumgartner C, Klok FA, Carrier M, Limacher A, Moor J, Righini M, Beer JH, Peluso M, Rakovic D, Huisman MV, Aujesky D. Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE). BMJ Open. 2020 Nov 19;10(11):e040151. doi: 10.1136/bmjopen-2020-040151.
Other Identifiers
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2019-02297
Identifier Type: -
Identifier Source: org_study_id
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