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 sites1,100 target enrollmentNovember 18, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute low-risk pulmonary embolism (PE)
Sponsor: niversity Medical Center of the Johannes Gutenberg University Mainz
Enrollment: 1100
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

November 18, 2013

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Medical Center 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

•\-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;