Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cerebral Vein Thrombosis
- Deep Vein Thrombosis
- Malignant Neoplasm
- Metastatic Malignant Neoplasm
- Pulmonary Embolism
- Splanchnic Vein Thrombosis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Any episode of major bleeding including fatal bleeding or clinically relevant non-major bleeding. SECONDARY OBJECTIVES: I. The proportion of patients who experienced at least one such bleeding event within 6 months of beginning treatment. II. Venous thromboembolism (VTE) recur...
PRIMARY OBJECTIVES: I. Any episode of major bleeding including fatal bleeding or clinically relevant non-major bleeding. SECONDARY OBJECTIVES: I. The proportion of patients who experienced at least one such bleeding event within 6 months of beginning treatment. II. Venous thromboembolism (VTE) recurrence including deep vein thrombosis (DVT), pulmonary embolism (PE), fatal PE, or arterial thromboembolism. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive lower dose apixaban orally (PO) twice daily (BID) for 365 days. GROUP II: Patients receive higher dose apixaban PO BID for 365 days. After completion of study treatment, patients are followed up for 12 months.
Tracking Information
- NCT #
- NCT03080883
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Robert D McBane Academic and Community Cancer Research United
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