Venous thromboembolism Venous thromboembolism,
Conditions
Interventions
The patients assigned to the apixaban group will receive a tablet of apixaban 2.5mg orally twice daily for a duration of 1 months. The participants are allowed to temporarily stop taking apixaban if t
Active Comparator Drug,Placebo Comparator Drug
Apixaban,Placebo
Sponsors
Faculty of Medicine, Chiang Mai university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria Subjects must meet all of the inclusion criteria to participate in this study. 1. Age ≥ 18 years 2. Any cancer with spine metastasis 3. Life expectancy ≥ 6 months 4. Provide written informed consent
Exclusion criteria
Exclusion criteria: Exclusion criteria Subjects meeting any of the exclusion criteria at baseline screening will be excluded from study participation. 1. History of major bleeding that in judgment of the investigator precludes use of anticoagulant prophylaxis 2. History of significant hepatic diseases or any condition that in the judgement of the investigator precludes the use of apixaban 3. Creatinine clearance less than 30 ml/min (calculated by Cockcroft-Gault formula) 4. Platelet count less than 75 x 109 /L 5. Need for long-term anticoagulation due to preexisting co-morbid condition or due to the development of VTE following surgery but prior to randomization 6. Chronic daily aspirin use with dose greater than 100 mg per day 7. Known allergies to ingredients contained in apixaban 8. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The first episode of objectively documented VTE (DVT and/or PE) within the 2 months at 60 days objectively documented VTE by U/S or CTPA | — |
Secondary
| Measure | Time frame |
|---|---|
| clinically major bleeding and minor bleeding episodes, and overall survival rates within the study p at 60 days clinical assessment | — |
Countries
Thailand
Contacts
Public ContactChatree Chai-Adisaksopha
Faculty of Medicine, Chiang Mai university
Outcome results
None listed