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

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

• Pulmonary Embolism
• Embolism
• Embolism and Thrombosis
• Lung Diseases
• Cardiovascular Diseases
• Respiratory Tract Diseases
• Venous Thromboembolism
• Anticoagulant-induced Bleeding
• Bleeding

Interventions

DRUG

Rivaroxaban

Anticoagulation

DRUG

Placebo

Study drug without active agent

Sponsors & Collaborators

• University of Bern

  collaborator OTHER

• Schweizerischer Nationalfonds

  collaborator OTHER

• Leiden University Medical Center

  collaborator OTHER

• The Ottawa Hospital

  collaborator OTHER

• Bayer

  collaborator INDUSTRY

• Drahomir Aujesky

  lead OTHER

Principal Investigators

• Drahomir Aujesky, Prof. MD MSc · Inselspital, Bern University Hospital, University of Bern

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-15

Primary Completion

2028-05-31

Completion

2028-05-31

Countries

• Belgium
• Canada
• France
• Netherlands
• Switzerland

Study Locations