Comparing clinical surveillance to anticoagulation for low-risk patients with isolated pulmonary embolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the efficacy and safety of clinical surveillance without anticoagulation versus anticoagulation treatment in low-risk patients diagnosed with isolated subsegmental pulmonary embolism (SSPE). The study will involve randomizing participants to receive either rivaroxaban or a placebo, assessing whether withholding anticoagulation is a safe option for selected patients. The trial addresses the uncertainty surrounding the clinical significance of isolated SSPE and aims to clarify the potential benefits and risks of anticoagulant treatment in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• Cliniques Universitaires Saint-Luc
  Woluwe-Saint-Lambert, Brussels Capital, Belgium Recruiting
• Centre hospitalier universitaire de Liege
  Liège, Belgium Recruiting
• The Ottawa Hospital
  Ottawa, Canada Recruiting
• Hôpital Bicêtre - APHP
  Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France Recruiting
• Centre Hospitalier Regional Et Universitaire De Brest
  Brest, France Recruiting
• CHU Gabriel-Montpied
  Clermont-Ferrand, France Recruiting

Study contacts

• Study coordinator: Drahomir Aujesky, Prof. MD MSc
• Email: SAFE-SSPE@insel.ch
• Phone: +41 31 632 88 84

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.