Cancer-associated venous Thromboembolism
Conditions
Interventions
None listed
Sponsors
International University of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older at the time of informed consent 2. Patients who have any of solid cancer. 3. Patients who developed venous thromboembolism (acute pulmonary thromboembolism or acute deep vein thrombosis) after cancer incidence and started treatment with the study drugs. It does not matter whether it is symptomatic or asymptomatic. 4. Patients who have provided written consent for participation in this study within 12 weeks after the start of administration of the study drugs
Exclusion criteria
Exclusion criteria: 1. Patients who have passed at least 2 weeks from diagnosis of VTE to the start of anticoagulant therapy. 2. Patients to whom the study drugs are contraindicated (see the package inserts) 3. Patients with active hemorrhage at the time of diagnosis of VTE 4. Other patients who are judged to be inappropriate by the physician in charge Ex. Inability or unwillingness to comply with the study related procedures, or employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator, etc. 5. Patients who are unlikely to receive anticoagulant therapy over three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence/aggravation of symptomatic venous thromboembolism All the patients suspected for efficacy or safety events and all the cases of death will be judged by the event evaluation committee based on detailed data to decide the event applicable. The event evaluation committee is authorized to ask the physician in charge for the supply of additional information necessary for the judgment of these events. Each endpoint will be assessed by descriptive statistics, and will not be compared between study drugs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically relevant bleeding events Clinically irrelevant bleeding events We define ISTH major bleeding as clinically relevant bleeding events. Thus, clinically irrelevant bleeding events include bleeding not meeting ISTH major bleeding, but requiring medical intervention, unscheduled consultation with a physician, temporary discontinuation of study treatment, pain, or impairment of daily activities. And we are planning to establish external event judgement committee. All adverse events PE-DVT clot regression (disappearance, reduction, no change, or aggravation of PE and DVT are assessed by CT scanning and lower-extremity venous ultrasound, respectively) It will be assessed by CT scanning and lower-extremity venous ultrasound (Yamada N et al., Thrombosis J., 17; 13: 2, 2015). Relation with antitumor agents (effect of metabolism by CYP3A4) Implementation of chemotherapy as planned Implementation of surgical intervention as planned Treatment compliance to outpatient treatment Hospitalization and duration of hospitalization for treatment of VTE Deaths (VTE-related deaths, cardiovascular deaths, cancer deaths, all deaths) Recurrence of symptomatic VTE in the patients who have completed or discontinued treatment for VTE Change in D-dimer Change in INR (only in the patients treated with warfarin) Performance status (PS) Evaluation of risk factors in the ASCO guidelines (such as venous device) All the patients suspected for efficacy or safety events and all the cases of death will be judged by the event evaluation committee based on detailed data to decide the event applicable. The event evaluation committee is authorized to ask the physician in charge for the supply of additional information necessary for the judgment of these events. Each endpoint will be assessed by descriptive statistics, and will not be compared between study drugs. | — |
Countries
Japan
Contacts
Public ContactYuichi Tamura
International University of Health and Welfare Cardiovascular internal medicine
Outcome results
None listed