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

  • STATUS
    Recruiting
  • End date
    Apr 15, 2024
  • participants needed
    276
  • sponsor
    Drahomir Aujesky
Updated on 15 March 2021
thrombosis
clot
cancer
anticoagulants
rivaroxaban
drug test
anticoagulant
deep vein thrombosis
pulmonary embolism
anticoagulation therapy

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, Embolism, Vascular Diseases, Venous Thromboembolism, Respiratory Tract Diseases, Pulmonary Embolism, Cardiovascular Disease, Thromboembolism, Lung Disease, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, thrombosis and embolism, pulmonary diseases, lung diseases, pulmonary disorders, cardiovascular diseases, cardiovascular disease (cvd), cardiovascular system diseases, cardiovascular disorders, respiratory tract disease, lung embolism, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding, Anticoagulant-induced Bleeding
Treatment Placebo, Rivaroxaban
Clinical Study IdentifierNCT04263038
SponsorDrahomir Aujesky
Last Modified on15 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Embolism and Thrombosis or Vascular Diseases or Venous Thromboembolism or Pulmonary Disease or Hemorrhage or Respiratory Tract Diseases or Pulmonary E...?
Do you have any of these conditions: pulmonary disorders or Hemorrhage or Pulmonary Disease or Pulmonary Embolism or cardiovascular diseases or cardiovascular disease (cvd) or Cardiovascu...?
Do you have any of these conditions: cardiovascular disease (cvd) or Pulmonary Embolism or Hemorrhage or thrombosis and embolism or lung diseases or Anticoagulant-induced Bleeding or Vasc...?
Do you have any of these conditions: lung embolism or respiratory tract disease or thrombosis and embolism or Lung Disease or Hemorrhage or Cardiovascular Disease or pulmonary diseases or...?
Do you have any of these conditions: lung embolism or Vascular Diseases or Thromboembolism or Lung Disease or cardiovascular disease (cvd) or respiratory tract disease or Cardiovascular D...?
Informed Consent as documented by signature
Age 18 years
Objective diagnosis of symptomatic or asymptomatic isolated SSPE

Exclusion Criteria

Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
Clinical instability (systolic blood pressure <100 mm Hg or arterial Oxygen saturation <92% at ambient air) at the time of presentation
Active bleeding or at high risk of bleeding
Severe renal failure (creatinine clearance <30ml/min)
Severe liver insufficiency (Child-Pugh B or C)
Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
Known hypersensitivity to rivaroxaban
Need for therapeutic anticoagulation for another reason
Therapeutic anticoagulation for >72 hours for any reason at the time of screening
Hospitalized for >72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
Lack of safe contraception in women of childbearing potential
Refusal or inability to provide informed consent
Prior enrolment in this trial
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