EUCTR2006-005328-18-PT
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. Thrombolysis in Acute Pulmonary Embolism - PEITHO
ConditionsPatients with intermediate severity pulmonary embolismMedDRA version: 20.0 Level: LLT Classification code 10014521 Term: Embolism pulmonary System Organ Class: 100000004855Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsMétalyse
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with intermediate severity pulmonary embolism
- Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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\)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
AEUCTR2006-005328-18-ITASSISTANCE PUBLIQUE HÔPITAUX DE PARIS/ DE`LE`GATION A` LA RECHERCHE CLINIQUE ET AU DE`VELOPPEMENT1,000
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. - PEITHOPatients atteints d'embolie pulmonaire de gravité intermédiaireEUCTR2006-005328-18-BEASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)1,000
Completed
Not Applicable
Pulmonary embolism diagnosis studyISRCTN65486961Queen Elizabeth II Health Science Centre (Nova Scotia) (Canada)1,530
Not yet recruiting
Phase 3
Pulmonary Embolism International Thrombolysis Trial: A reduced dose of thrombolytic treatment for patients with intermediate high-risk acute pulmonary embolism: a randomized controlled trial.NL-OMON56449Assistance Publique - Hôpitaux de Paris, Clinical Research and Innovation Direction (DRCI)75
Recruiting
Not Applicable
Pulmonary embolism and/or deep vein thrombosis in COVID-19 patients.COVID19Deep vein ThrombosisU07.1I26.9COVID-19, virus identifiedPulmonary embolism without mention of acute cor pulmonaleDRKS00021604Zollernalb Klinikum Balingen100