Cancer associatated thrombosis
Conditions
Interventions
Patients who consent to study participation should undergo a screening/run-in period of up to 120 hours to confirm eligibility criteria. A SoC treatment for VTE (e.g., recommended dose of a direct ora
Sponsors
Hara Yochiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male or female subjects are eligible for study participation if they have confirmed (histology, adequate imaging modality) diagnosis of cancer (other than basal-cell or squamous cell carcinoma of the skin) and presentation with acute VTE, for which long-term treatment with DOACs is indicated. The key eligibility criteria include (all the following must be met at the screening and randomization visits): - Male or female subjects >= 18 years old or another legal maturity age according to the country of residence - Confirmed diagnosis of cancer (by histology or adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following: - Active cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or - Currently receiving or having received anticancer therapy(radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months. - Confirmed symptomatic or incidental proximal lower limb DVT (i.e.,popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic PE, or an incidental PE in a segmental, or larger pulmonary artery. Patients are eligible within 120 hours from diagnosis of the qualifying VTE.
Exclusion criteria
Exclusion criteria: - Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE - More than 120 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants - An indication to continue treatment with therapeutic doses of an anticoagulant other than that used for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE) - Platelet count 180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent VTE is either: - Confirmed new symptomatic or incidental proximal DVT of the legs, iliac veins and/or inferior vena cava - Confirmed new symptomatic PE - Confirmed new incidental PE located in segmental or more proximal arteries. - Fatal PE (including unexplained death for which PE cannot be ruled out). | — |
Countries
Australia, Austria, Canada, China, Czechia, France, Germany, Hungary, Ireland, Italy, Japan, Korea, Latvia, Netherlands, Norway, Spain, Sweden, Switzerland, Taiwan, USA
Contacts
Public ContactInquiry Receipt Center jRCT
IQVIA Services Japan G.K.
Outcome results
None listed