EUCTR2012-000255-13-HU进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Male or female (non-pregnant, non-breastfeeding women) ages 40 years and older anticipated to be severely immobilized for at least 24 hours after randomization hospitalized with:
- •- one of the following Primary Risk Criteria for VTE documented as the cause of the acute hospitalization:
- •o congestive heart failure,
- •o acute respiratory failure,
- •o acute infection without septic shock,
- •o acute rheumatic disorders,
- •o acute ischemic stroke with lower extremity hemiparesis or
- •hemiparalysis
- •3. Signed informed consent form must be present.
- •4. Patients must be:
- •Severely Immobilized for 24 hours during the current hospitalization either before randomization or anticipated to be Severely Immobilized for a total period of 24 hours after randomization*, and
- •Are anticipated to be either Severely or Moderately Immobilized for atotal of = 4 days following randomization in any type of care setting (e.g., hospital, intermediate care or rehabilitation center, managed care in home, etc.), and
- •Are anticipated to be Mildly Immobilized after hospital discharge.
- •*If the 24 hour period of severe immobility occurs before randomization, the patient must still be at least moderately immobilized at randomization.
- •Severe immobilization – Patient is totally confined by illness to bed or chair for 100% of time. The patient may be able to use a bedside commode or the hospital room toilet with assistance only.
- •Moderate immobilization – Patient is confined by illness to bed for more than 50% of the time during daytime hours, but may spend up to 50% of the time in bedside chair. Patient cannot walk distance of 10 meters in 1 attempt or is only able to do so with assistance. Independent mobility is restricted to use of the hospital room toilet.
- •Mild immobilization - Patient is expected to remain in bed or chair during daytime hours more than was usual prior to their hospitalization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4850
排除标准
- •a condition requiring and receiving prolonged anticoagulation or antiplatelets
- •active bleeding or at high risk of bleeding
- •unable to take oral medication
- •contraindication to anticoagulant therapy
- •general conditions in which subjects are not suitable to participate in the study
- •20. 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 Pgp inhibitor (See Appendix B).
- •25. Concomitant dual anti-platelet therapy daily [any 2 of the following:
- •aspirin, dipyridamole, or any thienopyridine (i.e., clopidogrel, prasugrel, ticlopidine, ticagrelor)]. Fixed combination of very low dose aspirin (= 50 mg) and persantine products (e.g., Aggrenox®) will not be considered dual anti-platelet therapy for the purposes of this protocol.
研究者
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