Trials / Completed
CompletedNCT03080883
Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation Therapy
A Phase III, Randomized, Controlled, Double-Blind Study Evaluating the Safety of Two Doses of Apixaban for Secondary Prevention of Cancer Related Venous Thrombosis in Subjects Who Have Completed at Least Six Months of Anticoagulation Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- Academic and Community Cancer Research United · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related venous thrombosis in cancer patients who have completed anticoagulation therapy. Apixaban may help in prevention by blocking some of the enzymes needed for venous thrombosis.
Detailed description
PRIMARY OBJECTIVE: 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 30 days.
Conditions
- Cerebral Vein Thrombosis
- Deep Vein Thrombosis
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
- Metastatic Malignant Solid Neoplasm
- Pulmonary Embolism
- Splanchnic Vein Thrombosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apixaban | Given PO |
Timeline
- Start date
- 2017-07-14
- Primary completion
- 2022-06-07
- Completion
- 2025-05-09
- First posted
- 2017-03-15
- Last updated
- 2025-05-18
- Results posted
- 2023-12-12
Locations
32 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03080883. Inclusion in this directory is not an endorsement.