acute venous thromboembolism event
Conditions
Brief summary
Clinically relevant bleeding (=composite of major bleeding events and clinically relevant non-major bleeding events (according to the ISTH)) at the end of the full-dose treatment period (or up to 12 months).
Detailed description
o Net clinical benefit is defined by the composite of clinically relevant bleeding, recurrent venous thromboembolism and major adverse ischemic cardiovascular and cerebrovascular events, at the end of the full-dose treatment period, or up to 12 months, o Clinically relevant bleeding, o Major bleeding, o Vascular events are the composite of recurrent venous thromboembolism, major adverse cardiovascular and cerebrovascular events, o VTE sequels are the composite of post-thrombotic syndrome and/or post-PE syndrome
Interventions
DRUGINNOHEP 10 000 UI anti-Xa/0
DRUG5 ml
DRUGCOUMADINE 2 mg
DRUGcomprimé sécable
DRUGCALCIPARINE SOUS CUTANEE 20 000 UI/0
DRUG8 ml
DRUGsolution injectable
DRUGCALCIPARINE SOUS CUTANEE 12 500 UI/0
DRUGHEPARINE CHOAY 25 000 UI/5 ml
DRUGSINTROM 4 mg
DRUGcomprimé quadrisécable
DRUGCOUMADINE 5 mg
DRUGRESITUNE 100 mg
DRUGLOVENOX 10 000 UI (100 mg)/1 ml
DRUGArixtra 7.5 mg/0.6 ml solution for injection
DRUGpre-filled syringe.
DRUGKARDEGIC 75 mg
DRUGFRAGMINE 7 500 U.l. anti Xa/0
DRUG75 ml
DRUG45 ml
DRUGFRAGMINE 10 000 U.l. anti Xa/1 ml
Sponsors
Centre Hospitalier Universitaire De Saint Etienne
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically relevant bleeding (=composite of major bleeding events and clinically relevant non-major bleeding events (according to the ISTH)) at the end of the full-dose treatment period (or up to 12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| o Net clinical benefit is defined by the composite of clinically relevant bleeding, recurrent venous thromboembolism and major adverse ischemic cardiovascular and cerebrovascular events, at the end of the full-dose treatment period, or up to 12 months, o Clinically relevant bleeding, o Major bleeding, o Vascular events are the composite of recurrent venous thromboembolism, major adverse cardiovascular and cerebrovascular events, o VTE sequels are the composite of post-thrombotic syndrome and/or post-PE syndrome | — |
Countries
France
Outcome results
None listed