MedPath

A

Phase 1
Active, not recruiting
Conditions
Patient suffering from acute pulmonary embolism presenting with right ventricular dysfunction and tested troponin I or T test
MedDRA version: 14.1Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2006-005328-18-IT
Lead Sponsor
ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS/ DE`LE`GATION A` LA RECHERCHE CLINIQUE ET AU DE`VELOPPEMENT
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Recruiting
Sex
All
Target Recruitment
1000
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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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