Deep vein thrombosis of
Conditions
Interventions
Rivaroxaban high-dose group:From day 1 to day 21 after enrollment, oral rivaroxaban is 15mg twice a day
Rivaroxaban orally 20 mg once a day from day 22 to day 90.
Rivaroxaban low-dose group:From day 1 to day 90 after enrollment, rivaroxaban was administered orally, 20 mg once a day.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Be between the ages of 18-80; 2. the first diagnosis of isolated distal deep vein embolism (diagnostic criteria study protocol) with one of the above risks of prolongation; 3. new thrombosis (definition: (1) acute symptoms (within 2 weeks); (2) Ultrasound: manifested as hypoechoic, thickened venous wall, anechoic or hypoechoic venous lumen, and incomplete compression of the vein. There is no or markedly diminished blood flow signal in the vein; (3) The level of D-dimer was significantly increased (>=500 ng/mL); ) 4. No other serious complications such as severe cardiovascular, liver and kidney insufficiency; 5. No bleeding tendency or taking drugs that affect blood clotting; 6. Willing and able to take rivaroxaban orally; 7. have signed informed consent;
Exclusion criteria
Exclusion criteria: 1. Oral or subcutaneous injection of other anticoagulant drugs before randomization; 2. the use of other interventions other than oral rivaroxaban (such as vena cava filter insertion, surgical thrombectomy, drug thrombolysis, etc.); 3. Clinically suspected or confirmed PE; 4. ipsilateral or contralateral proximal DVT; 5. Patients who have had an allergic reaction to rivaroxaban. 6. Pregnant or lactating women. 7. Have an active bleeding disorder, such as peptic ulcer, intracranial hemorrhage, etc. 8. Patients who have had stroke, myocardial infarction or other serious cardiovascular events. 9. Patients with severe liver and kidney insufficiency, such as liver function Child-Pugh grade C or above, creatinine clearance rate less than 30 mL/min, etc. 10. Patients who failed to complete the follow-up during the study period or were unable to understand the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent venous thromboembolism;The incidence of haemorrhage; | — |
Countries
China
Contacts
Public ContactTao Zhang
Peking University People's Hospital
Outcome results
None listed