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).

Daiichi Sankyo

Status and phase

Completed

Phase 3

Conditions

Thromboembolism

Venous Thromboembolism

Deep Vein Thrombosis (DVT)

Venous Thrombosis

Pulmonary Embolism (PE)

Treatments

Drug: low molecular weight heparin/unfractionated heparin

Drug: edoxaban tosylate(DU-176b)

Drug: warfarin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00986154

DU176b-D-U305

The Edoxaban Hokusai VTE Study

Details and patient eligibility

About

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.

Enrollment

8,292 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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