Apixaban in Preventing Secondary Cancer Related Blood Clots in Cancer Patients Who Have Completed Anticoagulation Therapy
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|ClinicalTrials.gov Identifier: NCT03080883|
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Vein Thrombosis Deep Vein Thrombosis Malignant Neoplasm Metastatic Malignant Neoplasm Pulmonary Embolism Splanchnic Vein Thrombosis||Drug: Apixaban||Phase 3|
I. Any episode of major bleeding including fatal bleeding or clinically relevant non-major bleeding.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Actual Study Start Date :||July 14, 2017|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2023|
Experimental: Group I (lower dose apixaban)
Patients receive lower dose apixaban PO BID for 365 days.
Experimental: Group II (higher dose apixaban)
Patients receive higher dose apixaban PO BID for 365 days.
- Proportion of patients who experience at least one bleeding event [ Time Frame: Up to 12 months ]Patients will be analyzed according to the drug they received. The analysis of major bleeding plus clinically relevant nonmajor bleeding events will primarily focus on those events which occurred during treatment or within 7 days of treatment discontinuation. Major bleeding events observed later will be described separately. Proportion of patients experiencing at least one bleeding event within 12 months of beginning treatment will be compared across the two study arms using a two-sample comparison of proportions with a one-sided alternative at a significance level of 5% (i.e. a ?Z? test).
- Proportion of patients who experienced at least one bleeding event [ Time Frame: Up to 6 months ]Will be compared using a two-sample comparison of proportions with a one-sided alternative at a significance level of 5%.
- Venous thromboembolism recurrence [ Time Frame: Up to 12 months ]The time to the first event of the composite deep vein thrombosis (DVT)/pulmonary embolism (PE) outcome will be analyzed and will be compared across the two study arms using a two-sample comparison of proportions with a one-sided alternative at a significance level of 5% (i.e. a ?Z? test).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080883
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|Principal Investigator:||Robert McBane||Academic and Community Cancer Research United|