Actively Recruiting
Pulmonary Embolism International THrOmbolysis Study-3
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-16
800
Participants Needed
98
Research Sites
364 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
J
Johannes Gutenberg University Mainz
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pulmonary Embolism International THrOmbolysis Study-3
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Objectively confirmed acute pulmonary embolism with first symptoms within 2 weeks before randomization
- Acute pulmonary embolism confirmed within 24 hours prior to randomization
- Elevated risk of early death, hemodynamic collapse, or pulmonary embolism recurrence indicated by specific clinical signs such as low systolic blood pressure, respiratory distress, or heart failure history
- Right ventricular dysfunction indicated by RV/LV diameter ratio greater than 1.0 on echocardiography or CT pulmonary angiography
- Elevated serum troponin I or T concentration above the local normal upper limit using a high-sensitivity assay
- Ability to randomize within 6 hours after confirmation of right ventricular dysfunction and myocardial injury
- Signed informed consent form
You will not qualify if you...
- Hemodynamic instability
- Active bleeding
- History of non-traumatic intracranial bleeding at any time
- Acute ischemic stroke or transient ischemic attack within the previous 6 months
- Known central nervous system neoplasm or metastasis
- Recent neurologic, ophthalmologic, abdominal, cardiac, thoracic, vascular, or orthopedic surgery or trauma within 3 weeks
- Platelet count less than 100 G/L
- INR greater than 1.4 or prothrombin time ratio less than 60%
- Use of antiplatelet agents other than low-dose aspirin or clopidogrel as specified
- Use of any direct oral anticoagulant within 12 hours before inclusion
- Uncontrolled hypertension with systolic blood pressure over 180 mm Hg at inclusion
- Known pericarditis or endocarditis
- Known significant bleeding risk as judged by investigator
- Thrombolytic treatment within the previous 4 days
- Vena cava filter insertion or pulmonary thrombectomy within the previous 4 days
- Participation in another interventional clinical study
- Previous enrollment in this study
- Known hypersensitivity to alteplase, gentamicin, excipients of Actilyse, or low-molecular weight heparin
- Known heparin-induced thrombocytopenia
- Severe liver disease including liver failure, cirrhosis, portal hypertension, or active hepatitis
- Acute symptomatic pancreatitis
- Gastrointestinal ulcers or esophageal varices documented within the past 3 months
- Known arterial aneurysm or vascular malformations
- Pregnancy, parturition within previous 30 days, or current breastfeeding
- Women of childbearing potential without a negative pregnancy test and without specified contraception
- Any other condition increasing risk as judged by investigator
- Life expectancy less than 6 months or inability to complete 6-month follow-up
- Patient under legal protection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 98 locations
1
Graz, Mediz Universität
Graz, Austria, 8036
Withdrawn
2
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria, 4020
Actively Recruiting
3
UCL Brussels
Brussels, Belgium
Not Yet Recruiting
4
KU Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
5
CHU Liège
Liège, Belgium, 4000
Not Yet Recruiting
6
Foothills Medical Centre
Calgary, Alberta, Canada
Not Yet Recruiting
7
Juravinski Hospital - Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada, ON L8V 1C3
Not Yet Recruiting
8
Hamilton General Hospital - Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Not Yet Recruiting
9
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Not Yet Recruiting
10
London Health Sciences Centre
London, Ontario, Canada
Not Yet Recruiting
11
The Ottawa Hopsital, General and Civic campuses
Ottawa, Ontario, Canada
Not Yet Recruiting
12
Jewish General Hospital
Montreal, Quebec, Canada
Not Yet Recruiting
13
CHU d'Angers
Angers, France, 49933
Actively Recruiting
14
CHU de Besançon - Hôpital Jean-Minjoz
Besançon, France, 25030
Actively Recruiting
15
CHU de Brest - Hôpital de la Cavale Blanche
Brest, France, 29000
Actively Recruiting
16
CHU de Tours - Hôpital Trousseau
Chambray-lès-Tours, France, 37170
Actively Recruiting
17
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied
Clermont-Ferrand, France, 63000
Actively Recruiting
18
AP-HP - hôpital Henri-Mondor
Créteil, France, 94010
Actively Recruiting
19
CHU de Grenoble - Hôpital Michallon
La Tronche, France, 38700
Actively Recruiting
20
AP-HP - hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
21
CHU de Lille - Institut Cœur Poumon
Lille, France, 59000
Withdrawn
22
HCL - Hôpital Edouard Herriot
Lyon, France, 69000
Withdrawn
23
HCL - Hôpital Edouard Herriot
Lyon, France, 69000
Actively Recruiting
24
HCL - Centre Hospitalier Lyon-Sud, Pierre-Bénite
Lyon, France, 69495
Actively Recruiting
25
AP-HM - Hôpital de la Timone
Marseille, France, 13000
Actively Recruiting
26
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France, 34000
Withdrawn
27
CHU de Nice - Hôpital Pasteur
Nice, France, 06000
Terminated
28
AP-HP - Hôpital Lariboisière
Paris, France, 75010
Withdrawn
29
AP-HP - hôpital européen Georges-Pompidou
Paris, France, 75015
Actively Recruiting
30
AP-HP - Hôpital Bichat-Claude-Bernard
Paris, France, 75018
Actively Recruiting
31
AP-HP - Hôpital Tenon
Paris, France, 75020
Actively Recruiting
32
HCL - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
Withdrawn
33
CHU de Saint-Étienne - Hôpital Nord
Saint-Etienne, France, 42055
Actively Recruiting
34
CHU de Strasbourg - Hôpital Civil
Strasbourg, France, 67000
Actively Recruiting
35
CHU de Toulouse - Hôpital Rangueil
Toulouse, France, 31000
Actively Recruiting
36
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Germany, 79189
Actively Recruiting
37
DRK Kliniken Berlin Köpenick
Berlin, Germany, 10117
Actively Recruiting
38
Berlin, DRK Kliniken Westend
Berlin, Germany, 14050
Withdrawn
39
Augustinerinnen Hospital
Cologne, Germany, 50678
Actively Recruiting
40
Cologne Universität Herzzentrum
Cologne, Germany, 50937
Not Yet Recruiting
41
Dresden, Städtisches Klinikum
Dresden, Germany, 01067
Actively Recruiting
42
Düsseldorf, Augusta-Krankenhaus
Düsseldorf, Germany, 40472
Not Yet Recruiting
43
Freiburg Universität
Freiburg im Breisgau, Germany, 79085
Actively Recruiting
44
Greifswald, Univ.-Medizin
Greifswald, Germany, 17489
Actively Recruiting
45
Hannover, Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
46
Leipzig, Univ.-Klinikum
Leipzig, Germany, 4103
Actively Recruiting
47
Mainz Universitätsmedizin, CTH
Mainz, Germany, 55131
Actively Recruiting
48
Mainz, Katholisches Klinikum
Mainz, Germany, 55131
Actively Recruiting
49
Universitätsmedizin Mannheim UMM
Mannheim, Germany, 68167
Actively Recruiting
50
Regensburg, Uniklinik
Regensburg, Germany, 93053
Withdrawn
51
Tübingen, Univ.-Klinikum
Tübingen, Germany, 72076
Actively Recruiting
52
Ulm, Universitätsklinikum
Ulm, Germany, 89081
Not Yet Recruiting
53
University Hospital Ancona / Ospedali Riunit
Ancona, Italy, 60020
Actively Recruiting
54
Spedali Riuniti - Cremona
Cremona, Italy, 26100
Actively Recruiting
55
Ospedale San Giuseppe - Empoli
Empoli, Italy, 50053
Not Yet Recruiting
56
Azienda Ospedaliera Careggi - Firenze
Florence, Italy, 50134
Actively Recruiting
57
Humanitas Hospital - Milano
Milan, Italy, 20089
Actively Recruiting
58
University of Perugia
Perugia, Italy, 06123
Actively Recruiting
59
Ospedale Ca Foncello - Treviso
Treviso, Italy, 31100
Actively Recruiting
60
Catharina hospital
Eindhoven, Netherlands
Not Yet Recruiting
61
Medisch Spectrum Twente
Enschede, Netherlands
Not Yet Recruiting
62
Martini hospital
Groningen, Netherlands
Not Yet Recruiting
63
Maasstad hospital
Rotterdam, Netherlands
Actively Recruiting
64
Antonius hospital
Sneek, Netherlands
Not Yet Recruiting
65
Haaglanden hospital
The Hague, Netherlands
Not Yet Recruiting
66
Isala hospital
Zwolle, Netherlands
Not Yet Recruiting
67
Medical University of Bialystok
Bialystok, Poland
Actively Recruiting
68
Department of Cardiac and Vascular Diseases
Krakow, Poland
Withdrawn
69
Medical University of Lodz
Lodz, Poland
Withdrawn
70
University of Warmia Mazury in Olsztyn - School of Medicine
Olsztyn, Poland, 11-041
Actively Recruiting
71
Poznan University of Medical Sciences
Poznan, Poland
Withdrawn
72
Medical University of Warsaw
Warsaw, Poland
Withdrawn
73
Hospital Garcia de Orta
Almada, Portugal
Not Yet Recruiting
74
Centro Hospitalar de Lisboa Norte/ Hospitalde Santa Maria
Lisbon, Portugal
Not Yet Recruiting
75
Centro Hospitalar de Lisboa Ocidental
Lisbon, Portugal
Not Yet Recruiting
76
Hospital Pedro Hispano
Matosinhos Municipality, Portugal
Not Yet Recruiting
77
Centro Hospitalar do Porto
Porto, Portugal
Not Yet Recruiting
78
Centro Hospitalar de Setubal
Setúbal, Portugal
Not Yet Recruiting
79
Spitalul Judetean de Urgenta Baia Mare
Baia Mare, Romania, 430031
Not Yet Recruiting
80
Bucuresti - Spitalul Clinic de Urgenta Sf. Pantelimon
Bucharest, Romania
Not Yet Recruiting
81
Spitalul Judetean de Urgenta Constanta
Constanța, Romania, 900591
Not Yet Recruiting
82
Iasi - St Spiridon Emergency Conty Hospital
Iași, Romania, 700111
Not Yet Recruiting
83
Institutul de Boli Cardio-Vasculare Timisoara
Timișoara, Romania
Not Yet Recruiting
84
Cardiology Clinic, Emergency Center, Clinical Center of Serbia
Belgrade, Serbia
Not Yet Recruiting
85
Cardiology Clinic, Clinical Center of Niš
Niš, Serbia
Not Yet Recruiting
86
Institute for Lung Diseases of Vojvodina, Sremska Kamenica
Novi Sad, Serbia
Not Yet Recruiting
87
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
88
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Actively Recruiting
89
Hospital Clinic
Barcelona, Spain, 08036
Actively Recruiting
90
Hospital Bellvitge
Barcelona, Spain, 08907
Actively Recruiting
91
Hospital Cartagena
Cartagena, Spain
Actively Recruiting
92
Hospital Galdakao
Galdakao, Spain, 48960
Actively Recruiting
93
Clínica Universitaria Navarra
Madrid, Spain, 28027
Withdrawn
94
Hospital Ramón y Cajal
Madrid, Spain, 28034
Actively Recruiting
95
Hospital Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
96
Hospital La Fe
Valencia, Spain, 46026
Actively Recruiting
97
Geneva University Hospital
Geneva, Switzerland, 1205
Not Yet Recruiting
98
Hôpital du Valais
Sion, Switzerland, 1951
Not Yet Recruiting
Research Team
O
Olivier SANCHEZ, MD PhD
CONTACT
Y
Yvann Frigout
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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