A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial

Who is this study for? Patients with Pulmonary Embolism
What treatments are being studied? Alteplase
Status: Recruiting
Location: See all (98) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

In this study, we will assess the efficacy and safety of a reduced dose of thrombolytic therapy given in addition to low-molecular-weight heparin in patients with intermediate-high-risk acute pulmonary embolism. Half of participants will receive thrombolytic treatment, while the other half will receive a placebo.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Objectively confirmed acute PE with first symptoms occurring 2 weeks or less before randomization. Objective confirmation is based on at least one of the following criteria: (a) at least one segmental ventilation-perfusion mismatch on lung scanning; (b) a spiral computed tomography pulmonary angiography or pulmonary angiography showing a filling defect or an abrupt obstruction of a segmental or more proximal pulmonary artery

• Acute PE confirmed within 24 hours prior to randomization

• Elevated risk of early death, or of hemodynamic collapse, or PE recurrence, indicated by at least one of the following criteria: (a) systolic blood pressure ≤ 110 mm Hg over at least 15 minutes upon enrolment, (b) temporary need for fluid resuscitation and/or treatment with low-dose catecholamines, provided that the patient could be stabilized within 2 hours of admission and maintains SBP of ≥ 90 mmHg and adequate organ perfusion without catecholamine infusion; (c) respiratory rate \> 20/min or oxygen saturation on pulse oximetry SpO2 \<90% o(or partial arterial oxygen pressure \< 60 mm Hg) at rest while breathing room air, (d) documented history of chronic symptomatic heart failure

• Right ventricular dysfunction indicated by RV/LV diameter ratio \>1.0 on echocardiography apical four-chamber or subcostal four-chamber view or on Computed Tomography Pulmonary Angiography (transverse plane)

• Serum troponin I or T concentration above the upper limit of local normal using a high-sensitivity assay

• Ability to randomize the patient within 6 hours after the investigator receives the results of the second of the two criteria for RV dysfunction (RV/LV diameter ratio \>1.0) and myocardial injury (serum troponin I or T concentration above the upper limit of local normal), whichever comes latest.

• Signed informed consent form

Locations
Other Locations
Austria
Graz, Mediz Universität
WITHDRAWN
Graz
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
Belgium
UCL Brussels
NOT_YET_RECRUITING
Brussels
KU Leuven
NOT_YET_RECRUITING
Leuven
CHU Liège
NOT_YET_RECRUITING
Liège
Canada
Foothills Medical Centre
NOT_YET_RECRUITING
Calgary
Hamilton General Hospital - Hamilton Health Sciences Corporation
NOT_YET_RECRUITING
Hamilton
Juravinski Hospital - Hamilton Health Sciences Corporation
NOT_YET_RECRUITING
Hamilton
Kingston Health Sciences Centre
NOT_YET_RECRUITING
Kingston
London Health Sciences Centre
NOT_YET_RECRUITING
London
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
The Ottawa Hopsital, General and Civic campuses
NOT_YET_RECRUITING
Ottawa
France
CHU d'Angers
RECRUITING
Angers
CHU de Besançon - Hôpital Jean-Minjoz
RECRUITING
Besançon
CHU de Brest - Hôpital de la Cavale Blanche
RECRUITING
Brest
CHU de Tours - Hôpital Trousseau
RECRUITING
Chambray-lès-tours
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied
RECRUITING
Clermont-ferrand
AP-HP - hôpital Henri-Mondor
RECRUITING
Créteil
CHU de Grenoble - Hôpital Michallon
RECRUITING
La Tronche
AP-HP - hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
CHU de Lille - Institut Cœur Poumon
WITHDRAWN
Lille
HCL - Centre Hospitalier Lyon-Sud, Pierre-Bénite
RECRUITING
Lyon
HCL - Hôpital Edouard Herriot
RECRUITING
Lyon
HCL - Hôpital Edouard Herriot
WITHDRAWN
Lyon
AP-HM - Hôpital de la Timone
RECRUITING
Marseille
CHU de Montpellier - Hôpital Lapeyronie
WITHDRAWN
Montpellier
CHU de Nice - Hôpital Pasteur
TERMINATED
Nice
AP-HP - Hôpital Bichat-Claude-Bernard
RECRUITING
Paris
AP-HP - hôpital européen Georges-Pompidou
RECRUITING
Paris
AP-HP - Hôpital Lariboisière
WITHDRAWN
Paris
AP-HP - Hôpital Tenon
RECRUITING
Paris
HCL - Centre Hospitalier Lyon-Sud
WITHDRAWN
Pierre-bénite
CHU de Saint-Étienne - Hôpital Nord
RECRUITING
Saint-etienne
CHU de Strasbourg - Hôpital Civil
RECRUITING
Strasbourg
CHU de Toulouse - Hôpital Rangueil
RECRUITING
Toulouse
Germany
Universitäts-Herzzentrum Freiburg - Bad Krozingen
RECRUITING
Bad Krozingen
Berlin, DRK Kliniken Westend
WITHDRAWN
Berlin
DRK Kliniken Berlin Köpenick
RECRUITING
Berlin
Augustinerinnen Hospital
RECRUITING
Cologne
Cologne Universität Herzzentrum
NOT_YET_RECRUITING
Cologne
Dresden, Städtisches Klinikum
RECRUITING
Dresden
Düsseldorf, Augusta-Krankenhaus
NOT_YET_RECRUITING
Düsseldorf
Freiburg Universität
RECRUITING
Freiburg Im Breisgau
Greifswald, Univ.-Medizin
RECRUITING
Greifswald
Hannover, Medizinische Hochschule Hannover
RECRUITING
Hanover
Leipzig, Univ.-Klinikum
RECRUITING
Leipzig
Mainz Universitätsmedizin, CTH
RECRUITING
Mainz
Mainz, Katholisches Klinikum
RECRUITING
Mainz
Universitätsmedizin Mannheim UMM
RECRUITING
Mannheim
Regensburg, Uniklinik
WITHDRAWN
Regensburg
Tübingen, Univ.-Klinikum
RECRUITING
Tübingen
Ulm, Universitätsklinikum
NOT_YET_RECRUITING
Ulm
Italy
University Hospital Ancona / Ospedali Riunit
RECRUITING
Ancona
Spedali Riuniti - Cremona
RECRUITING
Cremona
Ospedale San Giuseppe - Empoli
NOT_YET_RECRUITING
Empoli
Azienda Ospedaliera Careggi - Firenze
RECRUITING
Florence
Humanitas Hospital - Milano
RECRUITING
Milan
University of Perugia
RECRUITING
Perugia
Ospedale Ca Foncello - Treviso
RECRUITING
Treviso
Netherlands
Catharina hospital
NOT_YET_RECRUITING
Eindhoven
Medisch Spectrum Twente
NOT_YET_RECRUITING
Enschede
Martini hospital
NOT_YET_RECRUITING
Groningen
Maasstad hospital
RECRUITING
Rotterdam
Antonius hospital
NOT_YET_RECRUITING
Sneek
Haaglanden hospital
NOT_YET_RECRUITING
The Hague
Isala hospital
NOT_YET_RECRUITING
Zwolle
Poland
Medical University of Bialystok
RECRUITING
Bialystok
Department of Cardiac and Vascular Diseases
WITHDRAWN
Krakow
Medical University of Lodz
WITHDRAWN
Lodz
University of Warmia Mazury in Olsztyn - School of Medicine
RECRUITING
Olsztyn
Poznan University of Medical Sciences
WITHDRAWN
Poznan
Medical University of Warsaw
WITHDRAWN
Warsaw
Portugal
Hospital Garcia de Orta
NOT_YET_RECRUITING
Almada
Centro Hospitalar de Lisboa Norte/ Hospitalde Santa Maria
NOT_YET_RECRUITING
Lisbon
Centro Hospitalar de Lisboa Ocidental
NOT_YET_RECRUITING
Lisbon
Hospital Pedro Hispano
NOT_YET_RECRUITING
Matosinhos Municipality
Centro Hospitalar do Porto
NOT_YET_RECRUITING
Porto
Centro Hospitalar de Setubal
NOT_YET_RECRUITING
Setúbal
Romania
Spitalul Judetean de Urgenta Baia Mare
NOT_YET_RECRUITING
Baia Mare
Bucuresti - Spitalul Clinic de Urgenta Sf. Pantelimon
NOT_YET_RECRUITING
Bucharest
Spitalul Judetean de Urgenta Constanta
NOT_YET_RECRUITING
Constanța
Iasi - St Spiridon Emergency Conty Hospital
NOT_YET_RECRUITING
Iași
Institutul de Boli Cardio-Vasculare Timisoara
NOT_YET_RECRUITING
Timișoara
Serbia
Cardiology Clinic, Emergency Center, Clinical Center of Serbia
NOT_YET_RECRUITING
Belgrade
Cardiology Clinic, Clinical Center of Niš
NOT_YET_RECRUITING
Niš
Institute for Lung Diseases of Vojvodina, Sremska Kamenica
NOT_YET_RECRUITING
Novi Sad
Slovenia
University Medical Centre Ljubljana
RECRUITING
Ljubljana
Spain
Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Bellvitge
RECRUITING
Barcelona
Hospital Clinic
RECRUITING
Barcelona
Hospital Cartagena
RECRUITING
Cartagena
Hospital Galdakao
RECRUITING
Galdakao
Clínica Universitaria Navarra
WITHDRAWN
Madrid
Hospital Ramón y Cajal
RECRUITING
Madrid
Hospital Virgen del Rocío
RECRUITING
Seville
Hospital La Fe
RECRUITING
Valencia
Switzerland
Geneva University Hospital
NOT_YET_RECRUITING
Geneva
Hôpital du Valais
NOT_YET_RECRUITING
Sion
Contact Information
Primary
Olivier SANCHEZ, MD PhD
olivier.sanchez@aphp.fr
01 56 09 20 00
Backup
Yvann Frigout
yvann.frigout@aphp.fr
Time Frame
Start Date: 2021-08-04
Estimated Completion Date: 2028-08
Participants
Target number of participants: 800
Treatments
Experimental: Alteplase
Placebo_comparator: Placebo
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Boehringer Ingelheim, International Network of VENous Thromboembolism Clinical Research Networks, Johannes Gutenberg University Mainz, Life Sciences Research Partners (D Collen Research Foundation), Instituto de Salud Carlos III
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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