EUCTR2008-000228-13-FR进行中（未招募）1 期
A Multinational, Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Primary Prevention of Venous Thromboembolism in Acutely Ill Medical Patients with Restricted Mobility
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
- 12,300
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
- •1. Patient with an acute medical condition requiring bed rest for at least 3 days
- •2. Age =40 years
- •3. Hospitalized for at least one of the following medical conditions:
- •- Congestive heart failure (NYHA class III/IV)
- •- Acute respiratory failure (not requiring mechanical ventilation)
- •- Acute infection (without septic shock)*
- •- Acute rheumatic disorder*
- •- Acute episode of inflammatory bowel disease*
- •* Patients with these conditions should have at least one additional risk factor for VTE.
- •4. Signed written informed consent
- •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
- •Exclusion criteria related to study methodology:
- •1. Previous surgery with general anesthesia within 30 days before inclusion
- •2. Any major surgery planned during the investigational treatment period
- •3. Any treatment with other antithrombotic agents within 2 weeks prior to randomization or planned during the course of the study, such as:
- •- Parenteral anticoagulants (UFH, LMWH [i.e. enoxaparin, dalteparin, nadroparin,..], fondaparinux, bivalirudin, hirudin)
- •*Note: A patient may be included if thromboprophylaxis has been initiated with a single dose of UFH or LMWH administered at least 12 hours before randomization.
- •- Oral anticoagulants (vitamin K antagonists)
- •- GPIIb/IIIa antagonists: abciximab, eptifibatide, tirofiban
- •- Thrombolytic agents
- •*Note: Chronic treatment with antiplatelet agents such as low-dose aspirin (up to 325 mg/day), clopidogrel or ticlopidine in patients with coronary artery disease is allowed.
- •4. Subject who requires a curative anticoagulant or thrombolytic treatment
- •5. Acute stroke
- •6. Subject unlikely to comply with the protocol, e.g. uncooperative attitude, inability to give informed consent, return for follow-up visits, inability to receive daily injection (by a health care professional) after hospital discharge and unlikelihood of completing the study
- •7. Treatment with any investigational product or investigational device in the last 30 days or 5 half lives (if relevant) prior to randomization
- •8. Any previous exposure to AVE5026 (e.g. participation in any previous AVE5026 clinical trial).
- •9. Anticipated survival <6 months
- •Note: A patient may not be enrolled in the study more than once (i.e. randomized more than once).
- •Exclusion criteria related to enoxaparin:
- •10. Active major bleeding
- •11. Thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of enoxaparin sodium
- •12. Known hypersensitivity to enoxaparin sodium (e.g. pruritus, urticaria, anaphylactoid reactions)
- •13. Known hypersensitivity to heparin or pork products
- •14. Conditions with increased risk of hemorrhage, such as bacterial endocarditis, congenital or acquired bleeding disorders, active ulcerative and angiodysplastic gastrointestinal disease, hemorrhagic stroke, or shortly after brain, spinal, or ophtalmological surgery
- •Exclusion criteria related to AVE5026
- •15. End stage renal disease (estimated creatinine clearance <10 mL/min) or patients on dialysis
- •16. Pregnant or breast-feeding women
- •17. Women of childbearing potential not protected by highly effective contraceptive method of birth control as defined for contraception in the Informed Consent Form for the duration of the study and/or who are unwilling or unable to be tested for pregnancy
- •*Note: Pregnancy status should be checked by serum or urine pregnancy testing prior to exposure to the investigational product.
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