Venous thromboembolism
Conditions
Interventions
VTE patients receive the NHI-covered standard rivaroxaban treatment (30 mg/day for 3 weeks after initiation of treatment, followed by 15 mg/day).
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 20 to 75 years, with active cancer at diagnosis with VTE. Active cancer at baseline was defined as a diagnosis of cancer that occurred within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.
Exclusion criteria
Exclusion criteria: Patients contraindicated for rivaroxaban, with creatinine clearance <30 mL/min, with isolated distal DVT, within 6 months in the remaining days, with a vitamin K antagonist, with severe complication (significant liver disease, active bleeding or a high risk of bleeding contraindicating anticoagulant treatment, severe hypertension (a systolic blood pressure of more than 180 mm Hg or a diastolic blood pressure of more than 110 mm Hg)), pregnancy, and breast-feeding. Patients who the physician in charge judges are ineligible for the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clot regression evaluated by contrast-enhanced CT imaging (Imaging is performed at baseline, 3 weeks and 3 months days after initiation of treatment).The ratio of clot volume regression after 3 weeks or 3 months compared with the clot volume at baseline is investigated. In addition, the rate of normalization (no thrombus in legs and lungs) is also investigated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Recurrence of symptomatic DVT or PE 2)Hemorrhagic complications Major bleeding:Clinically definite reduction in Hb by 2.0 g/dL or more, Bleeding requiring 2 units or more of transfusion, Intracranial hemorrhage, retroperitoneal hemorrhage, and bleeding to death Non-major bleeding: Bleeding clinically associated with rivaroxaban not meeting the criteria for major bleeding | — |
Countries
Japan
Contacts
Public ContactNaohiko Nakanishi
Kyoto Prefectural University of Medicine Department of Cardiovascular Medicine
Outcome results
None listed