Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
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- STATUS
- Recruiting
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- participants needed
- 276
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- sponsor
- Drahomir Aujesky
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.
Details
| Condition | Pulmonary Disease, Embolism and Thrombosis, Hemorrhage, Hemorrhage, Embolism, Vascular Diseases, Vascular Diseases, Venous Thromboembolism, Venous Thromboembolism, Respiratory Tract Diseases, Pulmonary Embolism, Pulmonary Embolism, Cardiovascular Disease, Thromboembolism, Thromboembolism, Anticoagulant-induced Bleeding |
|---|---|
| Age | 18years - 100years |
| Treatment | Placebo, Rivaroxaban |
| Clinical Study Identifier | NCT04263038 |
| Sponsor | Drahomir Aujesky |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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