EUCTR2013-001657-28-IT进行中（未招募）1 期
Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban: Prospective Management Trial (HoT-PE) - HoT-PE
IVERSITY MEDICAL SCHOOL OF THE JOHANNES GUTENBERG UNIVERSITY MAINZ0 个研究点目标入组 1,100 人开始时间: 2021年1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
- 1,100
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) Ability of subject to understand character and individual consequences of clinical trial;
- •3) Signed and dated informed consent of the subject available before the start of any specific trial procedures;
- •4) Women of childbearing potential have to practice a medically accepted contraception (non-hormonal intrauterine device, two independent barriers, female or male surgical sterilization, or two years postmeno-pausal) during the trial, and a negative pregnancy test (serum or urine) should be available before inclusion in the trial;
- •5) Objectively confirmed diagnosis of acute PE by multidetector computed tomographic (CT) pulmonary angiography, pulmonary angiography, or V/Q lung scan according to established diagnostic criteria, with or without symptomatic deep vein thrombosis;
- •6) Absence of right ventricular (RV) enlargement or dysfunction, and of free floating thrombi in the right atrium or right ventricle on echocardiography or computed tomography.
- •On echocardiography, RV enlargement/dysfunction is absent when both criteria listed
- •below are met:
- •- Right/left ventricular end-diastolic diameter ratio < 0.9 (apical or subcostal 4-chamber
- •- No paradoxical motion of the interventricular septum
- •On CT angiography, RV enlargement/dysfunction is absent when the following criterion is
- •- Right/left short-axis diameter ratio < 0.9 (transverse plane)
- •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 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •1) Pregnancy or lactation;
- •2) Historyof hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product;
- •3) Participation in other clinical trials during the present clinical trial or within the last 6 months;
- •4) Medical or psychological condition that would not permit completion of the trial or signing of informed consent;
- •5) Hemodynamic instability at presentation, indicated by at least one of the following; (i) systolic boold pressure (SBP) < 100 mm Hg, or heart rate > 100 beats per minute, or SBP drop by >40 mm Hg, for >15 min; (ii) need for catecholamines to maintain adequate organ perfusion amd a systolic blood pressure of > 100 mm Hg; (iiiù9 need for cardiopulmonary resuscitation;
- •7) Chronic treatment with a vitamin K antagonist, rivaroxaban or any other ora or parental anticoagulant drug;
- •8) Use of a fibrinolytic agent, surgical thromectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE;
- •9) Need for supplemental oxygen asministration to maintain oxygen saturation > 90%;
- •10) Pain requiring parenteral administration of analgesic agents;
- •11) Other medical conditions/comorbidities requiring hospitalization;
- •12) Acute PE diagnosed in a patient already hospitalized for another condition;
- •13) Active bleeding or known significant bleeding risk;
- •14) Severe renal insufficiency (estimated GFR < 15 ml/min/1.73m2 by the MDRD formula) or end-stage renal disease;
- •15) Severe hepatic failure;
- •16) Concomitant administration of strong inhibitors of P-gp and CYP3A4 such as azole antimycotic agents or HIV protease inhibitors;
- •17) Need for long-term treatment vitamin K antagonist, or for antiplatelet agents except acetylsalicylic acid at a dosage =100 mg/day;
- •18) Non-compliance or inability to adhere to treatment or to the follow-up visits; or lack of a family enviroment or support system for home treatment;
- •19) life expectancy less than 3 months
研究者
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