EUCTR2004-001128-19-DK进行中（未招募）不适用
A Phase 2 Randomized, Double Blinded (BMS-562247 and enoxaparin), Active-Controlled (enoxaparin and warfarin), Parallel-Arm, Dose Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,666
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
- •Subjects undergoing either elective unilateral total knee replacement.
- •Subject must be willing and able to undergo bilateral ascending contrast
- •venography and be able to inject (self or caregiver) enoxaparin or placebo
- •subcutaneously.
- •Men and women who are not of a childbearing potential (i.e., who are
- •postmenopausal or surgically sterile), of any race, and ages 18 (or legal age of
- •consent) to 90 years of age
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to study drug
- •administration.
- •Hereditary (first degree) or acquired bleeding or coagulation disorder.
- •Suspected or documented pro-thrombotic disorder, e.g., anti-thrombin or protein
- •S deficiency, protein C deficiency or resistance. Factor V Leiden and prothrombin
- •G2 mutation will be excluded only if associated with a family history of VTE in
- •first degree relatives.
- •Known or suspected history of heparin-induced thrombocytopenia.
- •Known intracranial or intra-ocular hemorrhage within past 5 years prior to surgery.
- •Gastrointestinal bleeding within 90 days of surgery; endoscopically verified ulcer
- •disease within 30 days before surgery; recent (within 6 months of surgery)
- •clinically significant hemorrhoidal bleeding.
- •Hematuria (gross or macroscopic) within 30 days prior to surgery.
- •Brain, spinal, ophthalmologic, or major surgery or trauma within 90 days prior to
- •Known (VTE) disease within the past 12 months.
- •Uncontrolled hypertension (supine SBP > 160 mm Hg or DBP > 100 mm Hg) at the
- •time of screening.
- •Known diabetic proliferative retinopathy.
- •Active, severe chronic obstructive pulmonary disease (COPD), e.g., emphysema,
- •chronic obstructive bronchitis.
- •Myocardial infarction (MI), percutaneous coronary intervention (PCI; with or
- •without stenting), coronary artery bypass grafting (CABG), or acute coronary
- •syndrome (ACS) within last 6 months prior to surgery.
研究者
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