PER-072-08未知未知
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
sanofi-aventis Recherche & Development,0 个研究点目标入组 0 人开始时间: 2008年10月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 发起方
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
- 18 至 80（—）
入选标准
- •Acute symptomatic PE confirmed with or without confirmed acute symptomatic DVT of the lower extremities.
排除标准
- •Limitations of legal lower age (specific to each country).
- •Women with reproductive potential who are not using adequate contraceptive measures.
- •That written informed consent is not obtained.
- •Another indication different from the current PE episode for anticoagulants.
- •Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current PE episode.
- •Treatment with a therapeutic dose of any LMWH or UFH or fondaparinux for more than 36 hours immediately before the random distribution.
- •Life expectancy <6 months.
- •Participation in the previous 30 days in any other pharmacotherapy study with an unregistered research product.
- •Pregnancy.
- •Threatened abortion.
- •Major active bleeding.
- •Hemorrhagic tendencies or blood dyscrasias.
- •Surgical intervention of the recent or contemplated central nervous system of eyes, traumatic surgery that produces large open surfaces.
- •Lumbar puncture and other diagnostic or therapeutic procedures with potential for uncontrolled bleeding
- •Malignant hypertension.
- •Unsupervised patients with senility, alcoholism or psychosis, or some other type of lack of cooperation from the patient.
- •Known hypersensitivity to warfarin or any other component of this product.
- •Patients with hypersensitivity to enoxaparin sodium, heparin or pork products.
- •Any other contraindication listed on your local warfarin or enoxaparin label, not listed above (see Appendix C).
- •Breastfeeding.
- •Creatinine clearance <10 ml / min or end-stage renal failure *
- •Hypersensitivity to idraparinux or SSR126517E.
- •Known allergy to avidin or egg proteins.
研究者
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