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

NCT04263038 Phase 4 RECRUITING

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.

Details

Lead sponsor	Drahomir Aujesky
Phase	Phase 4
Status	RECRUITING
Enrolment	276
Start date	2020-05-15
Completion	2026-05

Conditions

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

Interventions

• Rivaroxaban
• Placebo

Primary outcomes

• Recurrent venous thromboembolism — Within 90 days of randomization
  Proportion of recurrent, clinically symptomatic, objectively confirmed venous thromboembolism (defined as recurrent fatal or nonfatal pulmonary embolism or lower limb deep vein thrombosis)

Countries

Belgium, Canada, France, Netherlands, Switzerland