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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Pulmonary Embolism, Embolism, Embolism and Thrombosis, Lung Diseases, Cardiovascular Diseases, Respiratory Tract Diseases, Venous Thromboembolism, Anticoagulant-induced Bleeding, Bleeding

In brief

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.

Key facts

Study ID

NCT04263038

Run by

Drahomir Aujesky

People needed

276

Starts

2020-05-15

Expected to finish

2028-05-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed Consent as documented by signature
• Age ≥18 years
• Objective diagnosis of symptomatic or asymptomatic isolated SSPE

You may not qualify if…

• Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
• Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
• ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
• Clinical instability (systolic blood pressure <100 mm Hg or arterial Oxygen saturation <92% at ambient air) at the time of presentation
• Active bleeding or at high risk of bleeding
• Severe renal failure (creatinine clearance <30ml/min)
• Severe liver insufficiency (Child-Pugh B or C)
• Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
• Known hypersensitivity to rivaroxaban
• Need for therapeutic anticoagulation for another reason
• Therapeutic anticoagulation for >72 hours for any reason at the time of screening
• Hospitalized for >72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
• Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
• Lack of safe contraception in women of childbearing potential
• Refusal or inability to provide informed consent
• Prior enrolment in this trial

Where it is running

• Hospital of Neuchâtel — Neuchâtel, Switzerland (enrolling)
• Centre hospitalier universitaire de Liege — Liège, Belgium (enrolling)
• The Ottawa Hospital — Ottawa, Canada (enrolling)
• Hôpital Bicêtre - APHP — Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France (enrolling)
• Centre Hospitalier Regional Et Universitaire De Brest — Brest, France (enrolling)
• CHU Gabriel-Montpied — Clermont-Ferrand, France (enrolling)
• Centre Hospitalier Universitaire De Dijon — Dijon, France (enrolling)
• Hospital Edouard Herriot — Lyon, France (enrolling)
• Hôpitaux universitaires de Marseille Timone AP-HM — Marseille, France (enrolling)
• CHU De Rouen — Rouen, France (enrolling)
• CHU ST Etienne - Hôpital Nord — Saint-Priest-en-Jarez, France (enrolling)
• Albert Schweitzer Ziekenhuis Dordrecht — Dordrecht, Netherlands (enrolling)
• Medisch Spectrum Twente — Enschede, Netherlands (enrolling)
• Leiden University Medical Center — Leiden, Netherlands (enrolling)
• Hospital of Bienne — Biel/Bienne, Canton of Bern, Switzerland (enrolling)
• Cantonal Hospital of St. Gallen — Sankt Gallen, Canton of St. Gallen, Switzerland (enrolling)
• University Hospital of Lausanne — Lausanne, Canton of Vaud, Switzerland (enrolling)
• Cantonal Hospital of Winterthur — Winterthur, Canton of Zurich, Switzerland (enrolling)
• Triemli Hospital — Zurich, Canton of Zurich, Switzerland (enrolling)
• Cantonal Hospital of Frauenfeld — Frauenfeld, Thurgau, Switzerland (enrolling)
• Cantonal Hospital of Baden — Baden, Switzerland (enrolling)
• University Hospital of Basel — Basel, Switzerland (enrolling)
• Regional Hospital of Emmental — Burgdorf, Switzerland (enrolling)
• Geneva University Hospital — Geneva, Switzerland (enrolling)
• Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Brussels Capital, Belgium (enrolling)

Full record on ClinicalTrials.gov

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