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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Rivaroxaban
  Anticoagulation
• Препарат Placebo
  Study drug without active agent

Первичные конечные точки

• Recurrent venous thromboembolism [Срок оценки: Within 90 days of randomization]

Вторичные конечные точки (2)

• Clinically significant bleeding [Срок оценки: Within 90 days of randomization]
• All-cause mortality [Срок оценки: Within 90 days of randomization]

Критерии участия

Критерии включения

• Informed Consent as documented by signature
• Age ≥18 years
• Objective diagnosis of symptomatic or asymptomatic isolated SSPE

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 23 центра

• Cantonal Hospital of Liestal — Liestal
• Cantonal Hospital of Aarau — Aarau
• University Hospital Inselspital — Bern
• Hospital of Bienne — Biel/Bienne
• Cantonal Hospital of Fribourg — Fribourg
• Cantonal Hospital of Lucerne — Lucerne
• Cantonal Hospital of Olten — Olten
• Cantonal Hospital of St. Gallen — Sankt Gallen
• … и ещё 15 центров

Франция · 8 центров

• Hôpital Bicêtre - APHP — Le Kremlin-Bicêtre
• Centre Hospitalier Regional Et Universitaire De Brest — Brest
• CHU Gabriel-Montpied — Clermont-Ferrand
• Centre Hospitalier Universitaire De Dijon — Dijon
• Hospital Edouard Herriot — Lyon
• Hôpitaux universitaires de Marseille Timone AP-HM — Marseille
• CHU De Rouen — Rouen
• CHU ST Etienne - Hôpital Nord — Saint-Priest-en-Jarez

Нидерланды · 6 центров

• Albert Schweitzer Ziekenhuis Dordrecht — Dordrecht
• Medisch Spectrum Twente — Enschede
• Leiden University Medical Center — Leiden
• Erasmus Universitair Medisch Centrum — Rotterdam
• Haaglanden Medisch Centrum — The Hague
• Isala Klinieken Zwolle — Zwolle

Бельгия · 2 центра

• Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert
• Centre hospitalier universitaire de Liege — Liège

Канада · 1 центр

• The Ottawa Hospital — Ottawa

Публикации

• Baumgartner C, Klok FA, Carrier M, Limacher A, Moor J, Righini M, Beer JH, Peluso M, Rakovic D, Huisman MV, Aujesky D. Clinical Surveillance vs. Anticoagulation For low-risk patiEnts with isolated SubSegmental Pulmonary Embolism: protocol for a multicentre randomised placebo-controlled non-inferiority trial (SAFE-SSPE). BMJ Open. 2020 Nov 19;10(11):e040151. doi: 10.1136/bmjopen-2020-040151. PMID 33444199

Идентификаторы

NCT: NCT04263038 · 2019-02297

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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