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Completed

NCT Number: NCT00986154

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).

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.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Deep Vein Thrombosis (DVT) Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Pulmonary Embolism (PE) Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site 1100, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

edoxaban tosylate(DU-176b)

Drug

edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment

low molecular weight heparin/unfractionated heparin

Drug

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

Warfarin

Drug

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

Primary outcomes

  1. Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE

    Time frame: 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 outcomes

  1. The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality

    Time frame: 12 months from time of randomization

  2. Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism (PE).

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 29, 2009
Registry last updated
Mar 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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