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临床试验/EUCTR2006-005328-18-IT
EUCTR2006-005328-18-IT进行中(未招募)1 期

PEITHO Pulmonary Embolism Thrombolysis Study A prospective, randomized, double-blind, placebo-controlled, international, multicentre, parallel-group comparison trial evaluating the efficacy and safety of single i.v. bolus tenecteplase plus standard anticoagulation as compared with standard anticoagulation in normotensive patients with acute pulmonary embolism and with echocardiographic (or spiral CT) and laboratory evidence of right ventricular dysfunction. - PEITHO Pulmonary Embolism Thrombolysis

ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS/ DE`LE`GATION A` LA RECHERCHE CLINIQUE ET AU DE`VELOPPEMENT0 个研究点目标入组 1,000 人开始时间: 2007年8月29日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
1,000

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

  • - - Age 18 years or older - Patients suffering from acute pulmonary embolism (first symptoms occurring within 15 days) - right ventricular dysfunction on echocardiography and tested troponin I or T positive
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • 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

  • - Haemodynamic collapse - Known significant bleeding risk - Administration of thrombolytics agents within the previous 4 days - Uncontrolled hypertension, defined as systolic BP>180 mmHg e/o diastolic BP>110 mmHg at randomisation - Pregnancy or women who does not use a medically accepted method of birth control - Known coagulation disorder

研究者

发起方
ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS/ DE`LE`GATION A` LA RECHERCHE CLINIQUE ET AU DE`VELOPPEMENT

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