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RECRUITING

NCT04430569

PHASE3

Pulmonary Embolism International THrOmbolysis Study-3

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2021-08-04

Completion Date

2028-08

Last Updated

2025-05-16

Healthy Volunteers

Conditions

Pulmonary Embolism

Interventions

DRUG

Alteplase

Alteplase single intravenous infusion of 0.6 mg/kg of estimated bodyweight with a maximum of 50 mg given over 15 minutes.

DRUG

Placebo

Placebo single intravenous infusion of 0.6 mg/kg of estimated bodyweight with a maximum of 50 mg given over 15 minutes.

Inclusion Criteria: * 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 Exclusion Criteria: * Hemodynamic instability * Active bleeding * History of non-traumatic intracranial bleeding, any time * Acute ischemic stroke or transient ischemic attack (TIA) within the previous 6 months * Known central nervous system neoplasm/metastasis * Neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular or orthopedic surgery or trauma within 3 previous weeks * Platelet count \< 100 G/L * INR \> 1.4. If INR not available: prothrombin time ratio \< 60%. If both INR and prothrombin time ratio are measured, INR is relevant for the assessment of this criterion. * Treatment with antiplatelet agents other than (a) acetylsalicylic acid (ASA) ≤ 100 mg once daily or (b) clopidogrel 75 mg once daily or (c) a single loading dose of ASA or clopidogrel. Dual antiplatelet therapy (ASA + clopidogrel) is not allowed. * Any direct oral anticoagulant within 12 hours of inclusion * Uncontrolled hypertension defined by SBP \> 180 mm Hg at the time of inclusion * Known pericarditis or endocarditis * Known significant bleeding risk according to the investigator's judgement * Administration of thrombolytic agents within the previous 4 days * Vena cava filter insertion or pulmonary thrombectomy within the previous 4 days * Current participation in another interventional clinical study * Previous enrolment in this study * Known hypersensitivity to alteplase, gentamicin (a residue of the Actilyse® manufacturing process present in trace amounts), any of the excipients of Actilyse®, or low-molecular weight heparin (LMWH) * Known previous immune heparin-induced thrombocytopenia * Known severe liver disease (grade ≥ 3) including liver failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis * Acute symptomatic pancreatitis * Gastrointestinal ulcers or esophageal varices, documented within the past 3 months * Known arterial aneurysm, arterial or venous malformations * Pregnancy or parturition within the previous 30 days or current breastfeeding. * Women of childbearing potential who do not have a negative pregnancy test at the inclusion visit and do not use one of the following methods of birth control: hormonal contraception or intrauterine device or bilateral tubal occlusion * Any other condition that the investigator feels would place the patient at increased risk upon start of the investigational treatment * Life expectancy of less than 6 months or inability to complete 6-month follow-up. * Patient under legal protection

Locations (98)

Graz, Mediz Universität

Graz, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

UCL Brussels

Brussels, Belgium

KU Leuven

Leuven, Belgium

CHU Liège

Liège, Belgium

Foothills Medical Centre

Calgary, Alberta, Canada

Juravinski Hospital - Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Hamilton General Hospital - Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hopsital, General and Civic campuses

Ottawa, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

CHU d'Angers

Angers, France

CHU de Besançon - Hôpital Jean-Minjoz

Besançon, France

CHU de Brest - Hôpital de la Cavale Blanche

Brest, France

CHU de Tours - Hôpital Trousseau

Chambray-lès-Tours, France

CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

Clermont-Ferrand, France

AP-HP - hôpital Henri-Mondor

Créteil, France

CHU de Grenoble - Hôpital Michallon

La Tronche, France

AP-HP - hôpital Bicêtre

Le Kremlin-Bicêtre, France

CHU de Lille - Institut Cœur Poumon

Lille, France

HCL - Hôpital Edouard Herriot

Lyon, France

HCL - Hôpital Edouard Herriot

Lyon, France

HCL - Centre Hospitalier Lyon-Sud, Pierre-Bénite

Lyon, France

AP-HM - Hôpital de la Timone

Marseille, France

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, France

CHU de Nice - Hôpital Pasteur

Nice, France

AP-HP - Hôpital Lariboisière

Paris, France

AP-HP - hôpital européen Georges-Pompidou

Paris, France

AP-HP - Hôpital Bichat-Claude-Bernard

Paris, France

AP-HP - Hôpital Tenon

Paris, France

HCL - Centre Hospitalier Lyon-Sud

Pierre-Bénite, France

CHU de Saint-Étienne - Hôpital Nord

Saint-Etienne, France

CHU de Strasbourg - Hôpital Civil

Strasbourg, France

CHU de Toulouse - Hôpital Rangueil

Toulouse, France

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany

DRK Kliniken Berlin Köpenick

Berlin, Germany

Berlin, DRK Kliniken Westend

Berlin, Germany

Augustinerinnen Hospital

Cologne, Germany

Cologne Universität Herzzentrum

Cologne, Germany

Dresden, Städtisches Klinikum

Dresden, Germany

Düsseldorf, Augusta-Krankenhaus

Düsseldorf, Germany

Freiburg Universität

Freiburg im Breisgau, Germany

Greifswald, Univ.-Medizin

Greifswald, Germany

Hannover, Medizinische Hochschule Hannover

Hanover, Germany

Leipzig, Univ.-Klinikum

Leipzig, Germany

Mainz Universitätsmedizin, CTH

Mainz, Germany

Mainz, Katholisches Klinikum

Mainz, Germany

Universitätsmedizin Mannheim UMM

Mannheim, Germany

Regensburg, Uniklinik

Regensburg, Germany

Tübingen, Univ.-Klinikum

Tübingen, Germany

Ulm, Universitätsklinikum

Ulm, Germany

University Hospital Ancona / Ospedali Riunit

Ancona, Italy

Spedali Riuniti - Cremona

Cremona, Italy

Ospedale San Giuseppe - Empoli

Empoli, Italy

Azienda Ospedaliera Careggi - Firenze

Florence, Italy

Humanitas Hospital - Milano

Milan, Italy

University of Perugia

Perugia, Italy

Ospedale Ca Foncello - Treviso

Treviso, Italy

Catharina hospital

Eindhoven, Netherlands

Medisch Spectrum Twente

Enschede, Netherlands

Martini hospital

Groningen, Netherlands

Maasstad hospital

Rotterdam, Netherlands

Antonius hospital

Sneek, Netherlands

Haaglanden hospital

The Hague, Netherlands

Isala hospital

Zwolle, Netherlands

Medical University of Bialystok

Bialystok, Poland

Department of Cardiac and Vascular Diseases

Krakow, Poland

Medical University of Lodz

Lodz, Poland

University of Warmia Mazury in Olsztyn - School of Medicine

Olsztyn, Poland

Poznan University of Medical Sciences

Poznan, Poland

Medical University of Warsaw

Warsaw, Poland

Hospital Garcia de Orta

Almada, Portugal

Centro Hospitalar de Lisboa Norte/ Hospitalde Santa Maria

Lisbon, Portugal

Centro Hospitalar de Lisboa Ocidental

Lisbon, Portugal

Hospital Pedro Hispano

Matosinhos Municipality, Portugal

Centro Hospitalar do Porto

Porto, Portugal

Centro Hospitalar de Setubal

Setúbal, Portugal

Spitalul Judetean de Urgenta Baia Mare

Baia Mare, Romania

Bucuresti - Spitalul Clinic de Urgenta Sf. Pantelimon

Bucharest, Romania

Spitalul Judetean de Urgenta Constanta

Constanța, Romania

Iasi - St Spiridon Emergency Conty Hospital

Iași, Romania

Institutul de Boli Cardio-Vasculare Timisoara

Timișoara, Romania

Cardiology Clinic, Emergency Center, Clinical Center of Serbia

Belgrade, Serbia

Cardiology Clinic, Clinical Center of Niš

Niš, Serbia

Institute for Lung Diseases of Vojvodina, Sremska Kamenica

Novi Sad, Serbia

University Medical Centre Ljubljana

Ljubljana, Slovenia

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Clinic

Barcelona, Spain

Hospital Bellvitge

Barcelona, Spain

Hospital Cartagena

Cartagena, Spain

Hospital Galdakao

Galdakao, Spain

Clínica Universitaria Navarra

Madrid, Spain

Hospital Ramón y Cajal

Madrid, Spain

Hospital Virgen del Rocío

Seville, Spain

Hospital La Fe

Valencia, Spain

Geneva University Hospital

Geneva, Switzerland

Hôpital du Valais

Sion, Switzerland

Clinical Research Directory

Pulmonary Embolism International THrOmbolysis Study-3

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (98)