Pregnancy (a negative serum or urine pregnancy test should be available for women of child-bearing potential before study inclusion) or lactation
Women of childbearing potential who do not practice a medically accepted highly effective contraception during the trial and one month beyond
History of 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
Participation in another clinical trial during the present clinical trial or within the last three months
Medical or psychological condition that would not permit completion of the trial or signing of informed consent
Use of a fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter to treat the index episode of PE
Treatment with any therapeutically dosed anticoagulant for more than 48 hours prior to enrolment
Need for long-term treatment with a low molecular weight heparin, vitamin K antagonists or NOAC, for an indication other than the index PE episode, or for antiplatelet agents except acetylsalicylic acid at a dosage =100 mg/day;
Active bleeding or known significant bleeding risk (e.g., gastrointestinal ulcer, malignant neoplasms, injuries or recent surgeries of the brain, spinal cord or eyes, recent intracranial bleedings, known or suspected esophagus varices, aneurysms or intraspinal or intracranial vascular abnormalities)
Artificial heart valves requiring treatment with an anticoagulant
Renal insufficiency with estimated creatinine clearance <30 ml/min/1.73m2
Chronic liver disease with aminotransferase levels two times or more above the local upper limit of normal range
Concomitant administration of strong inhibitors of P-glycoprotein like ketoconazole, cyclosporin, itraconazole or dronedarone
Unwillingness or inability to adhere to treatment or to the follow-up visits
Life expectancy less than 6 months

NCT02596555_exc_T6
Drug
fibrinolytic agent
NCT02596555_exc_T7
Procedure
surgical thrombectomy,
NCT02596555_exc_T8
Procedure
thrombus aspiration
NCT02596555_exc_T9
Procedure
bus aspi , or
NCT02596555_exc_T10
Procedure
cava filter
NCT02596555_exc_T11
Condition
PE
NCT02596555_exc_T12
Scope
fibrinolytic agent, surgical thrombectomy, interventional (catheter-directed) thrombus aspiration or lysis, or use of a cava filter
NCT02596555_exc_T13
Drug
anticoagulant
NCT02596555_exc_T14
Qualifier
therapeutically
NCT02596555_exc_T15
Temporal
more than 48 hours prior to enrolment
NCT02596555_exc_T16
Reference_point
enrolment
NCT02596555_exc_T17
Qualifier
long-term
NCT02596555_exc_T18
Drug
low molecular weight heparin
NCT02596555_exc_T19
Drug
vitamin K antagonists
NCT02596555_exc_T20
Drug
NOAC
NCT02596555_exc_T21
Condition
PE episode
NCT02596555_exc_T22
Drug
antiplatelet agents
NCT02596555_exc_T23
Negation
except
NCT02596555_exc_T24
Negation
other
NCT02596555_exc_T25
Qualifier
index
NCT02596555_exc_T26
Scope
ow molecular weight heparin, vitamin K antagonists or NOAC
NCT02596555_exc_T27
Drug
acetylsalicylic acid
NCT02596555_exc_T28
Multiplier
=100 mg/day;
NCT02596555_exc_T29
Scope
antiplatelet agents except acetylsalicylic acid at a dosage =100 mg/day
NCT02596555_exc_T30
Scope
low molecular weight heparin, vitamin K antagonists or NOAC, for an indication other than the index PE episode, or for antiplatelet agents except acetylsalicylic acid at a dosage =100 mg/day;
NCT02596555_exc_T31
Condition
Active bleeding
NCT02596555_exc_T32
Observation
bleeding risk
NCT02596555_exc_T33
Qualifier
significant
NCT02596555_exc_T34
Condition
gastrointestinal ulcer
NCT02596555_exc_T35
Condition
malignant neoplasms
NCT02596555_exc_T36
Condition
injuries
NCT02596555_exc_T37
Procedure
surgeries
NCT02596555_exc_T38
Qualifier
brain
NCT02596555_exc_T39
Qualifier
spinal cord
NCT02596555_exc_T40
Qualifier
eyes
NCT02596555_exc_T41
Scope
brain, spinal cord or eyes
NCT02596555_exc_T42
Condition
intracranial bleedings
NCT02596555_exc_T43
Condition
esophagus varices
NCT02596555_exc_T44
Condition
aneurysms
NCT02596555_exc_T45
Condition
vascular abnormalities)
NCT02596555_exc_T46
Qualifier
intracranial
NCT02596555_exc_T47
Qualifier
intraspinal
NCT02596555_exc_T48
Scope
intraspinal or intracranial
NCT02596555_exc_T49
Scope
gastrointestinal ulcer, malignant neoplasms, injuries or recent surgeries of the brain, spinal cord or eyes, recent intracranial bleedings, known or suspected esophagus varices, aneurysms or intraspinal or intracranial vascular abnormalities
NCT02596555_exc_T50
Device
Artificial heart valves
NCT02596555_exc_T51
Drug
anticoagulant
NCT02596555_exc_T52
Condition
Renal insufficiency
NCT02596555_exc_T53
Measurement
estimated creatinine clearance
NCT02596555_exc_T54
Value
<30 ml/min/1.73m2
NCT02596555_exc_T55
Condition
Chronic liver disease
NCT02596555_exc_T56
Measurement
aminotransferase
NCT02596555_exc_T57
Value
two times or more above the local upper limit of normal range
NCT02596555_exc_T58
Drug
inhibitors of P-glycoprotein
NCT02596555_exc_T60
Drug
ketoconazole
NCT02596555_exc_T61
Drug
cyclosporin
NCT02596555_exc_T62
Drug
itraconazole
NCT02596555_exc_T63
Drug
dronedarone
NCT02596555_exc_T59
Scope
ketoconazole, cyclosporin, itraconazole or dronedarone
NCT02596555_exc_T65
Observation
Life expectancy
NCT02596555_exc_T66
Value
less than 6 months