EUCTR2013-001657-28-ES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
niversity Medical Center of the Johannes Gutenberg University Mainz0 个研究点目标入组 1,100 人开始时间: 2016年10月28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
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
- •-Hemodynamic instability at presentation, indicated by at least one of the following: (i) systolic blood 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 and a systolic blood pressure of >100 mm Hg; (iii) need for cardiopulmonary resuscitation;
- •-Right ventricular (RV) enlargement or dysfunction, or free floating thrombi in the right atrium or right ventricle, detected by echocardiography or computed tomography;
- •-Treatment with low-molecular-weight heparin, fondaparinux, or unfractionated heparin for more than 48 hours, or more than a single dose of a vitamin K antagonist prior to inclusion in the study;
- •-Treatment with rivaroxaban, dabigatran, apixaban, edoxaban or any other new generation antithrombotics on admission;
- •-Use of a fibrinolytic agent, surgical thrombectomy, interventional (transcatheter) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE;
- •- Need for supplemental oxygen administration to maintain oxygen saturation >90%;
- •-Pain requiring parenteral administration of analgesic agents;
- •-Other medical conditions/comorbidities requiring hospitalization;
- •- Acute PE diagnosed in a patient already hospitalized for another condition;
- •- Pregnancy or lactation;
- •- Active bleeding or known significant bleeding risk;
- •-Severe renal insufficiency (estimated GFR <15 ml/min/1.73m2) or end-stage renal disease;
- •-Severe hepatic failure;
- •-Known allergy or intolerance to rivaroxaban;
- •-Concomitant administration of strong inhibitors of P-gp and CYP3A4 such as azole antimycotic agents or HIV protease inhibitors;
- •-Need for long-term treatment vitamin K antagonists, or for antiplatelet agents except acetylsalicylic acid at a dosage <100 mg/day;
- •-Non-compliance or inability to adhere to treatment or to the follow-up visits; or lack of a family environment or support system for home treatment;
- •-Life expectancy less than 3 months.
研究者
相似试验
进行中（未招募）
1 期
Home Treatment of Patients with Low-Risk Pulmonary Embolism with RivaroxabaAcute low-risk pulmonary embolism (PE)MedDRA version: 20.0Level: HLTClassification code 10037379Term: Pulmonary embolism and thrombosisSystem Organ Class: 100000004866EUCTR2013-001657-28-DEniversity Medical Center of the Johannes Gutenberg University Mainz1,100
进行中（未招募）
1 期
Home Treatment of Patients with Low-Risk Pulmonary Embolism with RivaroxabaAcute low-risk pulmonary embolism (PE)MedDRA version: 20.0Level: HLTClassification code 10037379Term: Pulmonary embolism and thrombosisSystem Organ Class: 100000004866EUCTR2013-001657-28-ITIVERSITY MEDICAL SCHOOL OF THE JOHANNES GUTENBERG UNIVERSITY MAINZ1,100
进行中（未招募）
1 期
Home Treatment of Patients with Low-Risk Pulmonary Embolism with RivaroxabaAcute low-risk pulmonary embolism (PE)MedDRA version: 20.0Level: HLTClassification code 10037379Term: Pulmonary embolism and thrombosisSystem Organ Class: 100000004866EUCTR2013-001657-28-NLniversity Medical Center of the Johannes Gutenberg University Mainz1,100
进行中（未招募）
1 期
Home Treatment of Patients with Low-Risk Pulmonary Embolism with RivaroxabaAcute low-risk pulmonary embolism (PE)MedDRA version: 19.0Level: HLTClassification code 10037379Term: Pulmonary embolism and thrombosisSystem Organ Class: 100000004866EUCTR2013-001657-28-FIniversity Medical Center of the Johannes Gutenberg University Mainz1,100
进行中（未招募）
1 期
Home Treatment of Patients with Low-Risk Pulmonary Embolism with RivaroxabaEUCTR2013-001657-28-GRniversity Medical Center of the Johannes Gutenberg University Mainz576