EUCTR2015-001830-12-DE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
niversity Medical Center of the Johannes Gutenberg University Mainz0 个研究点目标入组 700 人开始时间: 2015年7月20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:
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
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 the index PE episode; or for antiplatelet agents except a etylsalicylic 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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