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. Thrombolysis in Acute Pulmonary Embolism - PEITHO

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 1,000 人开始时间: 2007年9月10日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•- age 18 years or older;
•- acute PE (first symptoms occurring 15 days or less before randomisation)
•- right ventricular dysfunction confirmed by echocardiography or spiral computed tomography of the chest and a positive troponin I or T test.
•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 1000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 600

•- Haemodynamic collapse
•- Known significant bleeding risk
•- Administration of thrombolytic agents within the previous 4 days
•- Uncontrolled hypertension defined as systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg at randomisation
•- Pregnancy, lactation or parturition within the previous 30 days. Women of childbearing age must have a negative pregnancy test or use a medically accepted method of birth control
•- Known coagulation disorder (including vitamin K antagonists and platelet count <100 000/mm3)

发起方