Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 276
- 试验地点
- 52
- 主要终点
- Recurrent venous thromboembolism
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Age ≥18 years
- •Objective diagnosis of symptomatic or asymptomatic isolated SSPE
排除标准
- •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
研究组 & 干预措施
No anticoagulation
Patients 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.
干预措施: Placebo (Drug)
Anticoagulation
Patients 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.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Recurrent venous thromboembolism
时间窗: Within 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)
次要结局
- Clinically significant bleeding(Within 90 days of randomization)
- All-cause mortality(Within 90 days of randomization)
研究者
Drahomir Aujesky
Prof. Dr., MD, MSc
Insel Gruppe AG, University Hospital Bern