Low risk acute pulmonary embolism
Conditions
Interventions
Sponsors
University Medical Centre Johannes Gutenberg-University Mainz
Eligibility
Age
18 Years to 64 Years
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 < 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)
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome is symptomatic recurrent venous thromboembolism (VTE) or death related to pulmonary embolism within 3 months after enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) All-cause mortality within 7 days; 2) All-cause mortality within 3 weeks; 3) All-cause mortality within 3 months; 4) 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; 5) Rehospitalization due to PE (index or recurrent event) or to a bleeding event within 3 months; 6) Generic and disease-specific quality of life at baseline, 1 week, 3 weeks, and 3 months; 7) Treatment satisfaction using the Anti-Clot Treatment Scale (ACTS) at 3 weeks and 3 months; 8) Utilization of medical resources at 1 week, 3 weeks, and 3 months (based on data from patients recruited at German study sites); 9) All-cause mortality at one year. Safety outcomes: 1) Major bleeding, based on the ISTH definition, within 7 days, 3 weeks, and 3 months; 2) Clinically relevant bleeding, defined as a composite of major or clinically relevant non- major bleeding, within 7 days, 3 weeks, and 3 months; 3) Serious adverse events (SAE) within 7 days, 3 weeks, and 3 months A Serious Adverse Event is defined as an event that at any dose (including overdose): Results in death; Is life-threatening; Requires subject hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Is an important medical event. | — |
Countries
The Netherlands
Outcome results
None listed