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Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

RecruitingPhase 4Ages 18 Years - anyAllDrahomir Aujesky
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In plain words

What the trial is, and whether it could suit you

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 safet

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📋 Eligibility rules (as published)
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
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What it tests

  • Rivaroxaban
  • Placebo
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Where

40 sites
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Centre hospitalier universitaire de Liege
Liège, Belgium
The Ottawa Hospital
Ottawa, Canada
Hôpital Bicêtre - APHP
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

…and 32 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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