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

Phase 4
Recruiting
Conditions
Pulmonary Embolism
Embolism
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Venous Thromboembolism
Bleeding
Cardiovascular Diseases
Anticoagulant-induced Bleeding
Interventions
Drug: Placebo
Registration Number
NCT04263038
Lead Sponsor
Drahomir Aujesky
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
276
Inclusion Criteria
  1. Informed Consent as documented by signature
  2. Age ≥18 years
  3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Exclusion Criteria
  1. Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
  2. Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
  3. ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
  4. Clinical instability (systolic blood pressure <100 mm Hg or arterial Oxygen saturation <92% at ambient air) at the time of presentation
  5. Active bleeding or at high risk of bleeding
  6. Severe renal failure (creatinine clearance <30ml/min)
  7. Severe liver insufficiency (Child-Pugh B or C)
  8. Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
  9. Known hypersensitivity to rivaroxaban
  10. Need for therapeutic anticoagulation for another reason
  11. Therapeutic anticoagulation for >72 hours for any reason at the time of screening
  12. Hospitalized for >72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
  13. Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
  14. Lack of safe contraception in women of childbearing potential
  15. Refusal or inability to provide informed consent
  16. Prior enrolment in this trial

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
AnticoagulationRivaroxabanPatients in the anticoagulation group will receive rivaroxaban 15 mg twice daily for the first 21 days, followed by 20 mg once daily for an overall treatment duration of 90 days.
No anticoagulationPlaceboPatients in the group without anticoagulation will receive placebo twice daily for the first 21 days, followed by one tablet daily for an overall treatment duration of 90 days.
Primary Outcome Measures
NameTimeMethod
Recurrent venous thromboembolismWithin 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)

Secondary Outcome Measures
NameTimeMethod
Clinically significant bleedingWithin 90 days of randomization

Proportion of the composite of major and clinically relevant non-major bleeding

All-cause mortalityWithin 90 days of randomization

Proportion of deaths (all causes of death will be considered)

Trial Locations

Locations (39)

Centre hospitalier universitaire de Liege

🇧🇪

Liège, Belgium

Cliniques Universitaires Saint-Luc

🇧🇪

Sint-Lambrechts-Woluwe, Belgium

The Ottawa Hospital

🇨🇦

Ottawa, Canada

Centre Hospitalier Regional Et Universitaire De Brest

🇫🇷

Brest, France

CHU Gabriel-Montpied

🇫🇷

Clermont-Ferrand, France

Centre Hospitalier Universitaire De Dijon

🇫🇷

Dijon, France

Hôpital Bicêtre - APHP

🇫🇷

Le Kremlin-Bicêtre, France

Hospital Edouard Herriot

🇫🇷

Lyon, France

CHU De Rouen

🇫🇷

Rouen, France

CHU ST Etienne - Hôpital Nord

🇫🇷

Saint-Priest-en-Jarez, France

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Centre hospitalier universitaire de Liege
🇧🇪Liège, Belgium
Raphaelle Lopez Iglesias, MD
Contact

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