EUCTR2012-000255-13-FI进行中（未招募）1 期
Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients - APEX - Acute Medically Ill VTE Prevention with Extended Duration Betrixaban Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6,850
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria:
- •1. General. Male or female patients aged = 40 years.
- •2. Cause of Acute Hospitalization. At least one of the following as the cause of the acute hospitalization:
- •a. Acutely decompensated heart failure with prior symptomatic chronic heart failure
- •b. Acute respiratory failure in patients with chronic symptomatic lung disease
- •c. Acute infection without septic shock (e.g., with systolic blood pressure < 90 mmHg after fluid challenge that requires pressor therapy) at screening and randomization.
- •d. Acute rheumatic disorders including acute lumbar pain, sciatica, vertebral compression, rheumatoid arthritis, systemic lupus erythematosus, etc.
- •e. Acute ischemic stroke with lower extremity hemiparesis or hemiparalysis, or with immobility of other origin that satisfies protocol immobility requirements.
- •3. Eligibility Risk Factors. Any one of the following:
- •a. = 75 years of age, or
- •b. 60 through 74 years of age with D-dimer = 2ULN, or
- •c. 40 through 59 years of age with D-dimer = 2ULN and a history of either VTE (DVT or PE) or cancer (excluding non-melanoma carcinoma of the skin)
- •4. Immobilization.
- •a. Patients have been Severely Immobilized for 24 hours or are anticipated to be Severely Immobilized for 24 hours. Severely Immobilized means patients are confined to a bed or chair for the majority of the day and can only be independently mobile to the in-room toilet. In-bed/chair physical therapy is permitted.
- •b. After 24 hours of Severe Immobilization, patients are anticipated to be Severely Immobilized or Moderately Immobilized for 3 or more days. Moderately Immobilized means patients can be independently mobile to the in-room or ward toilet; can be mobilized by physical therapy or nursing staff; and can be off-ward with assistance.
- •5. Hemoglobin.
- •a. Hgb = 10.0 g/dL during current presentation prior to randomization. A single value of Hgb < 10.0 g/dL does not disqualify a patient. Hgb may be repeated after initial stabilization, e.g., after diuresis in patients with acute decompensated heart failure, or
- •b. Hgb = 9.5 g/dL from two (2) consecutive blood samples taken on consecutive days with stable or rising (i.e., not falling) values.
- •6. Length of Hospitalization.
- •a. Expected total length of current hospitalization = 3 days.
- •b. Enrollment occurs < 96 hours after hospitalization/presentation (e.g., in Emergency Department) for acute medical illness.
- •7. Contraception.
- •a. Women of childbearing potential must have a negative serum pregnancy test prior to randomization and must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include bilateral tubal ligation (women), vasectomy (men), oral contraceptive (women), contraceptive patch, anovulants without estrogen, intradermal contraceptive implant with progesterone, progestagen injections every three months or barrier methods (intra-uterine device, diaphragm, female condom, male condom).
- •b. Abstinence (as part of the patient current lifestyle to choose not to have sex at all) is an acceptable form of contraception, only insofar as patients agree to use another acceptable method of birth control, preferably a barrier method, if the patient becomes sexually active, please refer to 7. a.
- •c. Periodic abstinence (trying to check your chances of becoming pregnant by the calendar, ovulation, post-ovulation or symptothermal (checking temperature) methods, and withdrawal are
排除标准
- •1. Unable to receive nourishment by enteral administration (e.g., by mouth, feeding tube, PEG tube).
- •2. Anticipated need for prolonged anticoagulation during the trial.
- •3. Life expectancy < 8 weeks
- •4. In the opinion of the Investigator, it will not be possible to obtain an adequate bilateral compression ultrasound sonography (CUS) evaluation (e.g., patients with above the knee amputations, some patients with lower limb lymphoedema or obesity that prevents adequate compression)
- •5. Patients unwilling or unable to comply with study procedures (including the Visit 3 ultrasound procedure) or study medications.
- •At risk of increased bleeding due to:
- •6. Low body weight < 45 kg.
- •7. History of clinically significant bleeding (i.e., requiring medical attention) within 6 months prior to enrollment.
- •8. History of any significant gastrointestinal, pulmonary or urogenital bleeding, ongoing chronic peptic ulcer disease or ongoing or acute gastritis within 2 years prior to enrollment.
- •9. Admitting or concomitant diagnosis having resulted in or likely to require major surgery within 3 months prior to enrollment or while on study, or other invasive procedure performed within 3 months prior to enrollment or while on study.
- •10. Ophthalmic surgery or biopsy of a parenchymal organ within 3 months prior to enrollment.
- •11. Known history of bronchiectasis or active lung cancer; however, lung cancer patients post-treatment who have no evidence of residual disease may be enrolled.
- •12. End stage renal disease with CrCl <15 mL/min, or requiring dialysis, or likely to require dialysis within 3 months of enrollment.
- •13. History of:
- •a. spontaneous intracranial (IC) bleeding within 3 years prior to enrollment or
- •b. concurrent intracranial (IC) bleeding including hemorrhagic stroke
- •14. History of severe head trauma or other severe physical trauma within 3 months prior to enrollment
- •15. Known intracranial lesions, including neoplasm, metastatic
- •disease, arterio-venous malformation or aneurysm.
- •Concomitant conditions
- •16. Has severe renal insufficiency (i.e., CrCl between = 15 mL/min and < 30 mL/min) and requires a concomitant use of a strong P-gp inhibitor.
- •17. Contraindication to anticoagulant therapy
- •18. Known abnormality of liver function tests [ > 3x ULN for serum glutamic-oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST), serum glutamate pyruvate transaminase (SGPT)/alanine transaminase (ALT) or alkaline phosphatase (ALP), or > 2 x ULN for total bilirubin in the absence of Gilbert’s syndrome], active liver disease, or hepatic dysfunction (e.g., cirrhosis).
- •19. Known uncontrolled human immunodeficiency virus (HIV) infection, [i.e., severely neutropenic (ANC < 500/mm3) or anticipated to develop severe neutropenia during the study treatment period due to prior or planned chemotherapy, or have HIV with CD4 count < 100/mm3 within 6 months prior to enrollment] or known complication of HIV infection (e.g., pneumocystis carinii pneumonia, Kaposi’s sarcoma, etc.) at screening. Patients with stable HIV infection on adequate antiviral medication are eligible for enrollment although they may require the reduced dose of betrixaban if their antiviral therapy includes a strong P-gp inhibitor.
- •20. Concurrent or history of alcohol or drug abuse within 1 year prior to enrollment.
- •21. Shock with persistent systolic BP < 90 mmHg and/or requiring pharmacological support of blood pressure.
- •22. History of hypersensitivity to either of the stud
研究者
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