Anticoagulant-induced Bleeding, Bleeding, Cardiovascular Diseases, Embolism, Embolism and Thrombosis, Lung Diseases, Pulmonary Embolism, Respiratory Tract Diseases, Venous Thromboembolism
Conditions
Keywords
subsegmental pulmonary embolism
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 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.
Interventions
DRUGRivaroxaban
Anticoagulation
DRUGPlacebo
Study drug without active agent
Sponsors
Drahomir Aujesky
University of Bern
Schweizerischer Nationalfonds
Leiden University Medical Center
The Ottawa Hospital
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent venous thromboembolism | Within 90 days of randomization | Proportion of recurrent, clinically symptomatic, objectively confirmed venous thromboembolism (defined as recurrent fatal or nonfatal pulmonary embolism or lower limb deep vein thrombosis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically significant bleeding | Within 90 days of randomization | Proportion of the composite of major and clinically relevant non-major bleeding |
| All-cause mortality | Within 90 days of randomization | Proportion of deaths (all causes of death will be considered) |
Countries
Belgium, Canada, France, Netherlands, Switzerland
Contacts
CONTACTDrahomir Aujesky, Prof. MD MSc
CONTACTTobias Tritschler, Dr. MD MSc
STUDY_DIRECTORDrahomir Aujesky, Prof. MD MSc
Inselspital, Bern University Hospital, University of Bern
Outcome results
None listed