Apixaban for the prevention of venous thromboembolism in patients with spine metastasis, a randomized placebo-controlled trial
- Conditions
- Venous thromboembolismVenous thromboembolism,VTE,Deep vein thrombosis,DVT,Pulmonary embolism,PE
- Registration Number
- TCTR20191022003
- Lead Sponsor
- Faculty of Medicine, Chiang Mai university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method clinically major bleeding and minor bleeding episodes, and overall survival rates within the study p at 60 days clinical assessment