EUCTR2015-001830-12-FR进行中（未招募）1 期
Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism. - PEITHO-2
JOHANNES GUTENBERG UNIVERSITY0 个研究点目标入组 700 人开始时间: 2017年9月5日最近更新:
适应症
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
- 700
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)Age ?18 years;
- •2)Objectively confirmed diagnosis of acute PE by multidetector CT angiography, ventilation/perfusion lung scan, or selective invasive pulmonary angiography, according to established diagnostic criteria;
- •3)Absence of hemodynamic collapse/decompensation at presentation;
- •4)Intermediate-risk category of PE severity indicated by the presence of at least one of the following a, b, or c criteria:
- •a)At least one sign of RV pressure overload/dysfunction on CT angiography or echocardiography (8,23):
- •a1) on CT angiography, RV pressure overload/dysfunction is defined as RV/LV end-diastolic diameter ratio >1.0; or
- •a2) on echocardiography, RV pressure overload/dysfunction is defined by the presence of at least one of the following findings:
- •RV/LV end?diastolic diameter ratio >1.0 (apical or subcostal 4?chamber view);
- •RV end?diastolic diameter >30 mm (parasternal long?axis or short?axis view);
- •RV free wall hypokinesis (any view);
- •Tricuspid regurgitant jet velocity >2.6 m/s from the apical or subcostal 4?chamber view, or the parasternal short?axis view;
- •Absence of inspiratory collapse of the inferior vena cava.
- •b)Signs of myocardial injury as indicated by elevated troponin levels:
- •Troponin elevation is defined as an abnormal result of any validated troponin test based on the reference values determined by the local Department of Clinical Chemistry at each participating site;
- •c)Signs of (RV) failure as indicated by NT-proBNP levels >600 pg/ml
- •5)Signed and dated informed consent of the subject available.
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1)Pregnancy or women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond;
- •2)Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE;
- •3)Need for long-term treatment with a low molecular weight heparin, a vitamin K antagonists, or a new oral anticoagulant (rivaroxaban, dabigatran, apixaban or edoxaban), for an indication other than VTE; or for antiplatelet agents except acetylsalicylic acid at a dosage ?100 mg/day;
- •4)Active bleeding or known significant bleeding risk;
- •5)Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2;
- •6)Non-compliance or inability to adhere to treatment or to the follow-up visits;
- •7)Life expectancy less than 6 months.
研究者
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