distal deep vein thrombosis
Conditions
Interventions
Rivaroxaban and physical treatment group Rivaroxaban 15 mg tablets shall be orally administered after meal twice daily for 21 days after starting treatment (initial treatment period).Subsequently, t
Sponsors
Mie University Graduate School of Medicine Department of Cardiology and Nephrology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients who have been newly diagnosed with distal DVT by CUS shall meet the following criteria: (1) Male and female patients whose age is 20 years or older. (2) A written consent has been obtained (3) 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) D-dimer positive c) Thrombosis that is extensive, or close to the popliteal veins d) Having an active malignant disease e) Having a medical history of proximal DVT or PE f) Being hospitalized g) Idiopathic
Exclusion criteria
Exclusion criteria: 1) A patient who was allocated in this study previously 2) A patient who has already started an anticoagulant treatment including preventive medications for postoperative DVT at the orthopedic department etc. 3) A patient who has other diseases than DVT, which anticoagulants are indicated for 4) A patient who is not applicable for wearing an elastic stocking or an elastic wrap 5) A patient who has a medical history of hypersensitivity against rivaroxaban 6) A patient who has severe renal impairment [estimated creatinine clearance (CLCR) <30 ml/min: calculated from Cockcroft-Gault formula] 7) A patient with active bleeding 8) A patient who has hepatic impairment of Child-Pugh classification B and C 9) A pregnant or potentially pregnant female or a nursing female *Pregnancy shall be checked by hearing consultation. Even with a slight suspicion, the patient shall be excluded. 10) A patient who has been on a HIV protease inhibitor* 11) A patient who has been on a Cobicistat-containing product* 12) A patient who has been on an oral or injectable azole antifungal drug* 13) A patient who is suffering acute bacterial endocarditis 14) A patient who received a CNS surgery recently or has a cerebral hemorrhage which developed recently 15) A patient who has acute symptomatic PE, or acute proximal DVT with or without symptoms 16) A patient who has serious complications, of which life prognosis is considered to be <3 months 17) A patient who has uncontrolled hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg) 18) A patient who has participated in any clinical trials of other drugs or medical devices within 30 days prior to randomization 19) A patient who is not able to comply with series of processes related to the clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic non-fatal PE or fatal PE, within 90 days after starting the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Occurrences of recurrent distal DVT within 90 days after starting the study 2) Occurrences of symptomatic proximal DVT within 90 days after starting the study 3) Occurrences of asymptomatic proximal DVT within 90 days after starting the study 4) Occurrences of symptomatic pulmonary embolism (PE) (fatal or non-fatal) within 90 days after starting the study 5) Composite of 1) -4) 6) Occurrences of recurrent distal DVT within 120, 180, and 365 days after starting the study 7) Occurrences of symptomatic proximal DVT within 120, 180, and 365 days after starting the study 8) Occurrences of asymptomatic proximal DVT within 120, 180, and 365 days after starting the study 9) Occurrences of symptomatic PE (fatal or non-fatal) within 120, 180, and 365 days after starting the study 10) Composite of 6) -9) 11) Composite of 7) -9) 12) Change in thrombus volume in 8, 21, and 90 days after starting the study 13) Biomarkers related to fibrinolytic and coagulation system (D dimer, SF) 14) Occurrences of *clinically relevant bleeding events within 90, 120, 180, and 365 days after starting the study *clinically relevant bleeding events: composite endpoint of major bleeding events or other clinically relevant non-major bleeding events 15) Composite of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic PE (fatal or non-fatal), or clinically relevant bleeding events within 90, 120, 180, and 365 days after starting the study 16) Composite of asymptomatic proximal DVT, symptomatic proximal DVT, symptomatic PE (fatal or non-fatal), or major bleeding events within 90, 120, 180, and 365 days after starting the study | — |
Countries
Japan
Contacts
Public ContactYoshito Ogihara
Mie University Graduate School of Medicine Department of Cardiology and Nephrology
Outcome results
None listed