PER-119-08已完成未知
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
BRISTOL MYERS SQUIBB PERU S.A.,0 个研究点目标入组 112 人开始时间: 2008年12月2日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40 至 100（—）
入选标准
- •Patients must be willing and able to give written informed consent. Consent to participate in the study must be obtained before selection.
- •Hospitalized patients due to congestive heart failure, acute respiratory failure or infection (without septic shock), acute rheumatic disease or inflammatory bowel disease.
- •Except for patients with congestive heart failure or respiratory failure, patients should have an additional factor, including: 1) age> 75 3) cancer 4) BMI> 30 (See Appendix 4 for the BMI Table) 5) estrogenic hormonal treatment 6) chronic heart or respiratory failure
- •Patients with planned hospitalization for> 3 days after randomization
- •Severe or moderate mobility restriction (ie: prostrate or limited to a chair, walk to the bathroom or into the room; see section 6.9.1)
- •Men and women of any race, at least 40 years of age
排除标准
- •MEF who do not wish or cannot use an acceptable method to prevent pregnancy during the entire study period.
- •MEF that use a prohibited contraceptive method
- •Pregnant or breastfeeding women
- •Women with a positive pregnancy test at enrollment or before administration of the product under investigation
- •Patients with confirmed VTE
- •Patients with diseases that require ongoing treatment with a parenteral or oral anticoagulant, eg, patients with mechanical valves, atrial fibrillation eligible for warfarin treatment
- •Patients with conditions that require ongoing treatment with parenteral antiplatelet agents or two or more oral antiplatelet agents
- •Active liver disease evidenced through abnormal laboratory test findings (see physical and laboratory findings below)
- •Anemia or thrombocytopenia evidenced by abnormal laboratory test findings (see physical and laboratory findings below)
- •Severe kidney disease evidenced by a creatinine clearance <30 ml / min estimated using the Cockcroft and Gault method (see Section 6.3.1.2)
- •Hospitalized patients more than 48 hours before randomization
- •Patients who are not in a position to take oral medications
- •Patients who in the last 30 days have undergone surgery that may be associated with a risk of bleeding
- •Patients who in the last 14 days have received treatment for consecutive days consisting of: more than two doses of enoxaparin or another low molecular weight heparin; more than two doses of fondaparin; more than four doses of unfractionated heparin; an infusion of unfractionated heparin for more than 48 hours; or more than two doses of an oral anticoagulant.
- •Patients with active bleeding or high risk of bleeding
- •Patients who have invasive procedures scheduled during the treatment period
- •Patients in whom, in the opinion of the Researcher, it is not possible to obtain an adequate evaluation by means of bilateral ultrasound with compression
- •Patients with acute shock
- •Patients with a life expectancy <1 month
- •Abnormal hematological findings: Hemoglobin <9 g / dl, Platelet count <100,000 / mm3
- •Abnormal liver function tests: ALT or AST> 2 X LSN or bilirubin (direct or total)> 1.5 x LSN (except when an alternative causative factor has been identified [eg, Gilbert´s syndrome])
- •Known allergies or suspected enoxaparin allergy or previous thrombocytopenia induced by heparin
- •Treatment with bevacizumab (Avastin®) within the previous 6 months or scheduled use during the study period
- •Current treatment with oral anticoagulants
- •Current treatment with dual oral antiplatelet agents or aspirin in a dose> 165 mg.
- •Compulsory prisoners or institutionalized patients (involuntarily confined) may not be enrolled in this study for the treatment of a psychiatric or physical illness (eg an infectious disease).
- •Administration of any investigational medication currently or within 30 days prior to the scheduled enrollment of this study
- •Patients who are unwilling or unable to comply with the study medication instructions, including the use of enoxaparin
- •Patients who are unwilling or unable to comply with the study procedures (eg, bilateral compression ultrasound) specified in the protocol
- •Patients who have been previously randomized in an experimental study of apixaban
研究者
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