EUCTR2013-000315-24-FR进行中（未招募）1 期
Pharmaco-epidemiology of the treatment of the symptomatic pulmonary embolism among in-patients and 75 years old or more: prospective, multicentric PEAGE cohort
CHU SAINT-ETIENNE0 个研究点目标入组 1,500 人开始时间: 2019年5月16日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
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
入选标准
- •- Age > or = to 75 years
- •- Symptomatic pulmonary embolism confirmed by objective paraclinical
- •examination (CT or scintigraphy) with or without DVT associated
- •- Date of PE within 3 days
- •- Administration possible according to the recommended dosages of
- •anticoagulation whatever it is: UFH, LMWH (dalteparin, enoxaparin,
- •Fraxiparin, tinzaparin), fondaparinux, oral anticoagulants
- •(acenocoumarol, fluindione, warfarin) or oral anticoagulants direct according to AMM
- •(apixaban, dabigatran, edoxaban , rivaroxaban)
- •- Indication of anticoagulant therapy for a period of at least 6 months
- •- Prognosis vital compatible with 6 month follow up
- •- Written informed consent obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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 1500
排除标准
- •- prescribed anticoagulant treatment on therapeutic dose over 72 hours
- •- indication of a therapeutic dose anticoagulant treatment for another
- •- Inability for whatever reasons, to prescribe at least one recommended
- •anticoagulant treatment to VTE-PE treatment on heparin-induced
- •thrombocytopenia requiring argatroban, lepirudin or danaparoid
- •- bleeding
- •- PE occurring despite well conducted anticoagulant treatment
- •- Contraindications to recommended dose anticoagulant treatment
研究者
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