isolated calf deep vein thrombosis isolated calf deep vein thrombosis
Conditions
Interventions
Arm (1) oral administration with rivaroxaban + physical treatment
Arm (2) physical treatment
Rivaroxaban
Sponsors
Ogihara Yoshito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients who have been newly diagnosed with isolated calf deep vein thrombosis (DVT) by lower limbs venous ultrasonography shall meet the following criteria: (1) Male and female patients whose age is 20 years or more (2) Patients who have at least one of the following risks for extending distal DVT which are listed in the 9th edition of ACCP guidelines: a) Associated with swelling/pain b)Thrombosis that is extensive, or close to the popliteal veins c) Having an active malignant disease d) Having a medical history of proximal DVT or pulmonary embolism e) Being hospitalized and requiring bed rest for more than 72 hours.
Exclusion criteria
Exclusion criteria: (1) Having already started an anticoagulant treatment (2) other diseases than DVT, which anticoagulants are indicated for (3) Active bleeding (4) Hepatic impairment of Child-Pugh classification B and C (5) severe renal impairment(CLCR<30ml/min) (6) Pregnant, unwilling to practice contraception during the study, or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite end point of occurrence of symptomatic or asymptomatic proximal deep vein thrombosis and, symptomatic non-fatal or fatal pulmonary embolism | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy and safety, such as occurrence of any kinds of venous thromboembolism, change in thrombus volume, or occurrence of bleeding events | — |
Contacts
Public ContactYoshito Ogihara
Mie University Hospital
Outcome results
None listed