Informations générales (source: ClinicalTrials.gov)
A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial (PEITHO-3)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
août 2021
août 2028
17 mai 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Bicêtre | SANCHEZ Olivier | 18/04/2025 07:56:29 | Contacter | ||
| AP-HP - Hôpital Bichat | SANCHEZ Olivier | 18/04/2025 07:56:29 | Contacter | ||
| AP-HP - Hôpital Europeen Georges Pompidou | SANCHEZ Olivier | 18/04/2025 07:56:29 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | SANCHEZ Olivier | 18/04/2025 07:56:29 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | SANCHEZ Olivier | 18/04/2025 07:56:29 | Contacter | ||
| AP-HP - Hôpital Tenon | SANCHEZ Olivier | 18/04/2025 07:56:29 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - Hôpital de la Timone - 13000 - Marseille - France | Gabrielle Sarlon-Bartoli, MD | Contact (sur clinicalTrials) | |||
| AP-HP - hôpital Bicêtre - 94270 - Le Kremlin-Bicêtre - France | Laurent Savale, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Lariboisière - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| CHU d'Angers - 49933 - Angers - France | Pierre-Marie Roy, MD | Contact (sur clinicalTrials) | |||
| CHU de Besançon - Hôpital Jean-Minjoz - 25030 - Besançon - France | Nicolas Meneveau, MD | Contact (sur clinicalTrials) | |||
| CHU de Brest - Hôpital de la Cavale Blanche - 29000 - Brest - France | Francis Couturaud, MD | Contact (sur clinicalTrials) | |||
| CHU de Clermont-Ferrand - Hôpital Gabriel Montpied - 63000 - Clermont-Ferrand - France | Jeannot Schmidt, MD | Contact (sur clinicalTrials) | |||
| CHU de Grenoble - Hôpital Michallon - 38700 - La Tronche - France | Hélène Bouvaist, MD | Contact (sur clinicalTrials) | |||
| CHU de Lille - Institut Cœur Poumon - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU de Montpellier - Hôpital Lapeyronie - 34000 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU de Nice - Hôpital Pasteur - 06000 - Nice - France | Contact (sur clinicalTrials) | ||||
| CHU de Saint-Étienne - Hôpital Nord - 42055 - Saint-Étienne - France | Laurent Bertoletti, MD | Contact (sur clinicalTrials) | |||
| CHU de Strasbourg - Hôpital Civil - 67000 - Strasbourg - France | Patrick Ohlmann, MD | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Hôpital Rangueil - 31000 - Toulouse - France | Caroline Biendel-Piquet, MD | Contact (sur clinicalTrials) | |||
| CHU de Tours - Hôpital Trousseau - 37170 - Chambray-lès-Tours - France | Denis Angoulvant, MD | Contact (sur clinicalTrials) | |||
| HCL - Centre Hospitalier Lyon-Sud - 69495 - Pierre-Bénite - France | Contact (sur clinicalTrials) | ||||
| HCL - Centre Hospitalier Lyon-Sud, Pierre-Bénite - 69495 - Lyon - France | Donatien De Marignan | Contact (sur clinicalTrials) | |||
| HCL - Hôpital Edouard Herriot - 69000 - Lyon - France | Laurent Argaud, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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