EUCTR2020-000353-26-NL进行中（未招募）1 期
Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial
Bern University Hospital0 个研究点目标入组 276 人开始时间: 2021年4月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 276
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1)Informed Consent as documented by signature
- •2)Age =18 years
- •3)Objective diagnosis of symptomatic or asymptomatic isolated SSPE
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 156
排除标准
- •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 SSPE (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
研究者
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