Acute low-risk pulmonary embolism (PE) MedDRA version: 20.0 Level: HLT Classification code 10037379 Term: Pulmonary embolism and thrombosis System Organ Class: 100000004866
Conditions
Interventions
Trade Name: Xarelto 15 mg Filmtabletten
Product Name: Xarelto 15 mg Filmtabletten
Product Code: B01AF01
Pharmaceutical Form: Coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Conc
Sponsors
University Medical Center of the Johannes Gutenberg University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
Exclusion criteria: -Hemodynamic instability at presentation, indicated by at least one of the following: (i) systolic blood pressure (SBP) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 -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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - All-cause mortality within 7 days; - All-cause mortality within 3 weeks; - All-cause mortality within 3 months; - Overall duration of hospital stay (index event and repeated hospitalizations due to PE [index or recurrent event] or to a bleeding event) within 3 months; - Rehospitalization due to PE (index or recurrent event) or to a bleeding event within 3 months; - Generic and disease-specific quality of life at baseline, 1 week, 3 weeks, and 3 months; - Treatment satisfaction at 3 weeks and 3 months; - Utilization of health care resources at 3 weeks and 3 months; - All-cause mortality at one year. Safety outcomes: - Major bleeding, based on the ISTH definition, within 7 days, 3 weeks, and 3 months; - Clinically relevant bleeding, defined as a composite of major or clinically relevant non- major bleeding, within 7 days, 3 weeks, and 3 months; - Serious adverse events (SAE) within 7 days, 3 weeks, and 3 months.;Timepoint(s) of evaluation of this end point: 7 days, 3 weeks, and 3 months | — |
Countries
Finland, Germany, Greece, Netherlands, Portugal, Spain
Contacts
Public ContactProf. Dr. S. Konstantinides
University Medical Center of the Johannes Gutenberg University Mainz
Outcome results
None listed