Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Phase 3

Completed

Conditions: Pulmonary Embolism (PE)
Venous Thromboembolism
Thromboembolism
Deep Vein Thrombosis (DVT)
Venous Thrombosis

Interventions: Drug: edoxaban tosylate(DU-176b)
Drug: low molecular weight heparin/unfractionated heparin
Drug: warfarin

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Male or female subjects older than the minimum legal adult age (country specific);
Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging;
Able to provide written informed consent

Exclusion Criteria

thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE;
More than 48 hours pre-treatment with anticoagulant therapy prior to randomization;
Calculated Creatinine clearance (CrCL) < 30 mL/min;
significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >\= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN;
patients with active cancer for whom long term treatment with (LMW) heparin is anticipated;
active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin;
chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs);
treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy;
concurrent treatment with potent P-gp inhibitors;
subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study

Arm && Interventions

Group	Intervention	Description
heparin/edoxaban tosylate	edoxaban tosylate(DU-176b)	-
heparin/edoxaban tosylate	low molecular weight heparin/unfractionated heparin	-
heparin/warfarin	low molecular weight heparin/unfractionated heparin	-
heparin/warfarin	warfarin	-

Primary Outcome Measures

Name	Time	Method
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE	12 months from time of randomization	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."

Secondary Outcome Measures

Name	Time	Method
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment	12 months from time of randomization	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.
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality	12 months from time of randomization

Locations (405): Investigational Site 7103
🇺🇸
Mobile, Alabama, United States
Investigational Site 7132
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Montgomery, Alabama, United States
Investigational Site 7126
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Phoenix, Arizona, United States
Investigational Site 7139
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Little Rock, Arkansas, United States
Investigational Site 1070
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Anaheim, California, United States
Investigational Site 7125
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Los Alamitos, California, United States
Investigational Site 1093
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Monterey, California, United States
Investigational Site 1069
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Palm Springs, California, United States
Investigational Site 7150
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San Diego, California, United States
Investigational Site 1089
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Vista, California, United States
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Investigational Site 7103
🇺🇸Mobile, Alabama, United States