Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8,292
edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment
LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily. Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment
tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment
Investigational Site 7103
Mobile, Alabama, United States
Investigational Site 7132
Montgomery, Alabama, United States
Investigational Site 7126
Phoenix, Arizona, United States
Investigational Site 7139
Little Rock, Arkansas, United States
Investigational Site 1070
Anaheim, California, United States
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period. Overall Study Period defined as "The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit."
Time frame: 12 months from time of randomization
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
Time frame: 12 months from time of randomization
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period.
Time frame: 12 months from time of randomization
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Investigational Site 7125
Los Alamitos, California, United States
Investigational Site 1093
Monterey, California, United States
Investigational Site 1069
Palm Springs, California, United States
Investigational Site 7150
San Diego, California, United States
Investigational Site 1089
Vista, California, United States
...and 444 more locations