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 sites1,100 target enrollmentJanuary 5, 2021

Overview

No summary available.

Registry

who.int

Start Date

January 5, 2021

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

IVERSITY MEDICAL SCHOOL OF THE JOHANNES GUTENBERG UNIVERSITY MAINZ

•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

•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;