EUCTR2006-001786-42-EE进行中（未招募）不适用
An international, multicenter, randomized, double-blind, double-dummy, parallel group, study of 3-month or 6-month treatment with SSR126517E (3.0 mg s.c. once weekly) versus oral INR-adjusted warfarin in the treatment of patients with symptomatic pulmonary embolism, with or without symptomatic deep venous thrombosis - CASSIOPEA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,200
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
- •Confirmed acute symptomatic PE with or without confirmed acute symptomatic DVT of the lower limbs.
- •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
- •1. Legal lower age limitations (country specific)
- •2. Women with childbearing potential without proper contraceptive measures
- •3. Written informed consent not obtained
- •4. Other indication than current episode of PE for anticoagulation
- •5. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
- •6. Treatment with a therapeutic dose of any LMWH or UFH or fondaparinux for more than 36 hours immediately preceding randomization
- •7. Life expectancy < 6 months
- •8. Participation, within the prior 30 days, in another pharmacotherapeutic study with non-registered investigational product
- •9. Pregnancy
- •10. Threatened abortion
- •11. Active major bleeding
- •12. Hemorrhagic tendencies or blood dyscrasias
- •13. Recent or contemplated surgery of central nervous system, eye, traumatic surgery resulting in large open surfaces
- •14. Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding
- •15. Malignant hypertension
- •16. Unsupervised patients with senility, alcoholism, or psychosis, or other lack of patient cooperation
- •17. Known hypersensitivity to warfarin or to any other component of this product
- •18. Patients with hypersensitivity to enoxaparin sodium, heparin, or pork products
- •19. Any other contraindication in your local warfarin or enoxaparin labeling, not listed above
- •20. Breast-feeding
- •21. Creatinine clearance < 10mL/min or end-stage renal failure (i.e. need for renal replacement therapy such as renal transplantation, hemodialysis or peritoneal dialysis).
- •22. Hypersensitivity to idraparinux or SSR126517E
- •23. Known allergy to avidin or egg proteins
研究者
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