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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04263038
Other study ID # 2019-02297
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date May 15, 2020
Est. completion date May 2026

Study information

Verified date May 2024
Source Insel Gruppe AG, University Hospital Bern
Contact Drahomir Aujesky, Prof. MD MSc
Phone +41 31 632 88 84
Email SAFE-SSPE@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 276
Est. completion date May 2026
Est. primary completion date May 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Informed Consent as documented by signature 2. Age =18 years 3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE Exclusion Criteria: 1. Presence of leg deep vein thrombosis (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 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

Study Design


Intervention

Drug:
Rivaroxaban
Anticoagulation
Placebo
Study drug without active agent

Locations

Country Name City State
Belgium Centre hospitalier universitaire de Liege Liège
Belgium Cliniques Universitaires Saint-Luc Sint-Lambrechts-Woluwe
Canada The Ottawa Hospital Ottawa
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
Netherlands Haaglanden Medisch Centrum Den Haag
Netherlands Albert Schweitzer Ziekenhuis Dordrecht Dordrecht
Netherlands Medisch Spectrum Twente Enschede
Netherlands Leiden University Medical Center Leiden
Netherlands Erasmus Universitair Medisch Centrum Rotterdam
Netherlands Isala Klinieken Zwolle Zwolle
Switzerland Cantonal Hospital of Aarau Aarau Aargau
Switzerland Cantonal Hospital of Uri Altdorf
Switzerland Cantonal Hospital of Baden Baden
Switzerland University Hospital of Basel Basel
Switzerland Tiefenau Hospital Bern
Switzerland University Hospital Inselspital Bern
Switzerland Hospital of Bienne Bienne Bern
Switzerland Regional Hospital of Emmental Burgdorf
Switzerland Hospital of Delémont Delémont
Switzerland Cantonal Hospital of Frauenfeld Frauenfeld Thurgau
Switzerland Cantonal Hospital of Fribourg Fribourg
Switzerland Geneva University Hospital Geneva
Switzerland University Hospital of Lausanne Lausanne Vaud
Switzerland Cantonal Hospital of Liestal Liestal Basel
Switzerland Cantonal Hospital of Lucerne Lucerne
Switzerland Hospital of Neuchâtel Neuchâtel
Switzerland Hospital of Nyon Nyon Vaud
Switzerland Cantonal Hospital of Olten Olten Solothurn
Switzerland Hospital of Sion Sion Valais
Switzerland Cantonal Hospital of St. Gallen St. Gallen Saint Gallen
Switzerland Cantonal Hospital of Winterthur Winterthur Zurich
Switzerland Triemli Hospital Zürich
Switzerland University Hospital Zürich Zürich

Sponsors (6)

Lead Sponsor Collaborator
Drahomir Aujesky Bayer, Leiden University Medical Center, Schweizerischer Nationalfonds, The Ottawa Hospital, University of Bern

Countries where clinical trial is conducted

Belgium,  Canada,  France,  Netherlands,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Health-related quality of life Pulmonary embolism related quality of life as assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire Within 90 days of randomization
Other Functional status Functional status as assessed by the post-venous thromboembolism functional status scale Within 90 days of randomization
Other Initial length of stay (LOS) Defined as the time/date of discharge minus time/date of admission at the emergency department Within 90 days of randomization
Other Subsequent overall hospitalizations Number of overall hospitalizations Within 90 days of randomization
Other Emergency departments and physician outpatient visits Number of emergency department and physician outpatient visits Within 90 days of randomization
Other Return to work or usual activities Time (days) to return to work in workers and usual activities (household) in non-workers Within 90 days of randomization
Primary Recurrent venous thromboembolism Proportion of recurrent, clinically symptomatic, objectively confirmed venous thromboembolism (defined as recurrent fatal or nonfatal pulmonary embolism or lower limb deep vein thrombosis) Within 90 days of randomization
Secondary Clinically significant bleeding Proportion of the composite of major and clinically relevant non-major bleeding Within 90 days of randomization
Secondary All-cause mortality Proportion of deaths (all causes of death will be considered) Within 90 days of randomization
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