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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Pulmonary
Title   Evaluation of efficacy and safety of (LMW) heparin/edoxaban versus (LMW) heparin/warfarin in subjects with symptomatic deep-vein thrombosis and/or pulmonary embolism (Pulmonary)
Description   To evaluate whether initial (Low Molecular Weight) heparin followed by edoxaban only ([LMW] heparin/edoxaban) is non-inferior to initial (LMW) heparin overlapping with warfarin, followed by warfarin only ([LMW] heparin/warfarin) in the treatment of subjects with acute symptomatic VTE for the prevention of symptomatic recurrent VTE during the 12-month study period.
IRB Number   Pro3051
Inclusion/Notes   INCLUSION:
  • 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:
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE.

  • Indication for warfarin other than DVT and/or PE.

  • More than 48 hours pre-treatment with therapeutic dosages of anticoagulant treatment (LMWH, UFH, and fondaparinux per local labeling) or more than a single dose of a VKA prior to randomization to treat the current episode.

  • Treatment with any investigational drug within 30 days prior to randomization.

  • Calculated 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) ³ 1.5 times the ULN.

  • Patients with active cancer for whom long term treatment with LMW(heparin) is anticipated.

  • Life expectancy < 3 months.

  • Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin.

  • Uncontrolled hypertension as judged by the investigator (e.g., systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg despite antihypertensives).

  • Women of childbearing potential without proper contraceptive measures, and women who are pregnant or breast feeding:
    Note: Childbearing potential without proper contraceptive measures (i.e., a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence, and vasectomy for the male partner).

  • Any other contraindication listed in the local labeling of LMWH, UFH, or warfarin.

  • Chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) including both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) inhibitors for ³ 4 days/week anticipated to continue during the study.

  • Treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy (any two antiplatelet agents including aspirin plus any other oral or invravenous (IV) antiplatelet drug) anticipated to continue during the study.

  • Treatment with the potent P-gp inhibitors ritonavir, nelfinavir, indinavir, or saquinavir anticipated to continue during the study.

  • Systemic use of the anti-arrythmic drug dronedarone at the time of randomization (subjects randomized to study prior to Amendment 2 will have their edoxaban dose reduced).

  • Systemic use of the strong P-gp inhibitors erythromycin, azithromycin, larithromycin, ketoconazole or itraconazole at the time of randomization; subsequent use is permitted.

  • Known history of positive Hepatitis B antigen or Hepatitis C antibody.

  • 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.
Status   Recruiting
Location   Physician / Investigator Office
Principal Name    Randall Todd Richwine DO
Contact Name   Lee Knox
Phone   (972) 739-3089

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