Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04263038

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

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial

Status
Recruiting
Phase
Phase 4
Study type
Interventional
Enrollment
276 (estimated)
Sponsor
Drahomir Aujesky · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGRivaroxabanAnticoagulation
DRUGPlaceboStudy drug without active agent

Timeline

Start date
2020-05-15
Primary completion
2026-05-01
Completion
2026-05-01
First posted
2020-02-10
Last updated
2025-05-30

Locations

39 sites across 5 countries: Belgium, Canada, France, Netherlands, Switzerland

Source: ClinicalTrials.gov record NCT04263038. Inclusion in this directory is not an endorsement.