Status:

RECRUITING

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

Lead Sponsor:

Drahomir Aujesky

Collaborating Sponsors:

University of Bern

Schweizerischer Nationalfonds

Conditions:

Pulmonary Embolism

Embolism

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 ...

Eligibility Criteria

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

Key Trial Info

Start Date :

May 15 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2026

Estimated Enrollment :

276 Patients enrolled

Trial Details

Trial ID

NCT04263038

Start Date

May 15 2020

End Date

May 1 2026

Last Update

May 30 2025

Active Locations (39)

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Page 1 of 10 (39 locations)

1

Centre hospitalier universitaire de Liege

Liège, Belgium

2

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

3

The Ottawa Hospital

Ottawa, Canada

4

Hôpital Bicêtre - APHP

Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France, 94270