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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Cleveland Clinic-Weston
Weston, Florida, United States
Northwestern University
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Start Date
July 14, 2017
Primary Completion Date
June 7, 2022
Completion Date
May 9, 2025
Last Updated
May 18, 2025
370
ACTUAL participants
Apixaban
DRUG
Lead Sponsor
Academic and Community Cancer Research United
Collaborators
NCT07102160
NCT05108519
Data Source & Attribution
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