Who is eligible for clinical trial NCT04430569?

Participants must meet protocol criteria for Pulmonary Embolism. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04430569 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-29

Pulmonary Embolism International THrOmbolysis Study-3 (NCT04430569)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Assistance Publique - Hôpitaux de Paris

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (29 items).

Location: Ordensklinikum Linz GmbH Elisabethinen — Linz

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (85 Sites)

Ordensklinikum Linz GmbH Elisabethinen — Linz,
UCL Brussels — Brussels,
KU Leuven — Leuven,
CHU Liège — Liège,
Foothills Medical Centre — Calgary, Alberta
Juravinski Hospital - Hamilton Health Sciences Corporation — Hamilton, Ontario
Hamilton General Hospital - Hamilton Health Sciences Corporation — Hamilton, Ontario
Kingston Health Sciences Centre — Kingston, Ontario
London Health Sciences Centre — London, Ontario
The Ottawa Hopsital, General and Civic campuses — Ottawa, Ontario
Jewish General Hospital — Montreal, Quebec
CHU d'Angers — Angers,
CHU de Besançon - Hôpital Jean-Minjoz — Besançon,
CHU de Brest - Hôpital de la Cavale Blanche — Brest,
CHU de Tours - Hôpital Trousseau — Chambray-lès-Tours,
CHU de Clermont-Ferrand - Hôpital Gabriel Montpied — Clermont-Ferrand,
AP-HP - hôpital Henri-Mondor — Créteil,
CHU de Grenoble - Hôpital Michallon — La Tronche,
AP-HP - hôpital Bicêtre — Le Kremlin-Bicêtre,
HCL - Hôpital Edouard Herriot — Lyon,
HCL - Centre Hospitalier Lyon-Sud, Pierre-Bénite — Lyon,
AP-HM - Hôpital de la Timone — Marseille,
CHU de Nice - Hôpital Pasteur — Nice,
AP-HP - hôpital européen Georges-Pompidou — Paris,
AP-HP - Hôpital Bichat-Claude-Bernard — Paris,

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗