This study is a multi-center, randomized, open-label, double-blind, positive-controlled phase II clinical study evaluating the efficacy and safety of different doses of SHR2285 tablets vs. enoxaparin for the prevention of postoperative venous thromboembolism in patients undergoing elective unilateral total knee arthroplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
SHR2285 tablet; dose 1, for 12 days
SHR2285 tablet; dose 2, for 12 days
SHR2285 tablet; dose 3, for 12 days
Perking Union Medical College Hospital
Beijing, Beijing Municipality, China
Number of patients with confirmed composite endpoint
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) or all-cause deaths
Time frame: Day 12
Number of patients with composite bleeding
Occurrence of confirmed composite endpoint of major bleeding and clinically relevant non-major (CRNM) bleeding events
Time frame: Day 12
Number of patients with composite venous thromboembolic events (VTE)
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) ,all-cause deaths
Time frame: Day 1 to Day 12
Number of patients with composite venous thromboembolic events (VTE)
Occurrence of confirmed composite endpoint of asymptomatic deep vein thrombosis (DVT), Confirmed symptomatic/non-symptomatic venous thromboembolic events (VTE), non-fatal pulmonary embolism (PE) ,all-cause deaths
Time frame: Day 1 to Day 42
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SHR2285 tablet; dose 4, for 12 days
Enoxaparin, for 12 days