Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial - SAFE-SSPE

Insel Gruppe AG0 个研究点目标入组 324 人开始时间: 2023年9月19日最近更新: 2024年7月22日

适应症

试验速览

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•Informed Consent as documented by signature, Age =18 years, Objective diagnosis of symptomatic or asymptomatic isolated SSPE, Affiliation to the general health insurance regime (only for study sites in France)

•Presence of leg DVT or upper extremity DVT (subclavian vein or above), 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 SSPE (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 (specification for study sites in France: guardianship, conservatorship, judicial protection or unprotected person with a cognitive impairment that does not allow sufficient understanding of the study procedures), Prior enrolment in this trial, Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months; or presence of metastatic cancer, =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

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