EUCTR2006-005328-18-IT
Active, not recruiting
Phase 1
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 sites1,000 target enrollmentAugust 29, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS/ DE`LE`GATION A` LA RECHERCHE CLINIQUE ET AU DE`VELOPPEMENT
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- \- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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