Home Treatment of Patients with Low-Risk Pulmonary Embolism with Rivaroxaba
- Conditions
- Acute low-risk pulmonary embolism (PE)MedDRA version: 19.0Level: HLTClassification code 10037379Term: Pulmonary embolism and thrombosisSystem Organ Class: 100000004866Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-001657-28-PT
- Lead Sponsor
- niversity Medical Center of the Johannes Gutenberg University Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1100
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
view)
- No paradoxical motion of the interventricular septum
On CT angiography, RV enlargement/dysfunction is absent when the following criterion is
met:
- 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
-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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether early discharge and out-of-hospital treatment of patients with low-risk acute PE (as defined by the inclusion and exclusion criteria) with the new oral factor Xa inhibitor rivaroxaban is feasible, effective, and safe.;Secondary Objective: -To determine whether early discharge and out-of-hospital treatment of low-risk acute PE with the new oral factor Xa inhibitor rivaroxaban can result in good quality of life and patient satisfaction<br>-To obtain valid health economic variables as a basis for description of resource utilization, including validation of a disease-specific quality of life questionnaire, and of existing Markov models.;Primary end point(s): Symptomatic recurrent venous thromboembolism (VTE) or death related to pulmonary embolism;Timepoint(s) of evaluation of this end point: within 3 months after enrolment
- Secondary Outcome Measures
Name Time Method