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Could a lower dose of a Clot-Buster be safer and still effective for dangerous blood clots in the lungs?

NCT ID NCT04430569

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether a reduced dose of the clot-dissolving drug alteplase, given alongside standard blood thinners, can improve outcomes for people with intermediate-high-risk pulmonary embolism (a serious blood clot in the lungs). About 800 adults with confirmed acute pulmonary embolism will receive either the reduced-dose alteplase or a placebo, and researchers will track deaths, worsening heart function, and recurrent clots. The goal is to find a safer balance between breaking up dangerous clots and avoiding severe bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Alteplase
What this could lead to
If successful, this could establish a safer, effective dosing strategy for clot-busting drugs in pulmonary embolism, reducing complications while maintaining benefit.
What could go wrong
This is a single trial with 800 participants; results may not apply to all patients. Even a reduced dose carries bleeding risk, and the lower dose might prove less effective than standard therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary embolism

Contacts and locations

Locations

  • AP-HM - Hôpital de la Timone

    Marseille, 13000, France

  • AP-HP - Hôpital Bichat-Claude-Bernard

    Paris, 75018, France

  • AP-HP - Hôpital Tenon

    Paris, 75020, France

  • AP-HP - hôpital Bicêtre

    Le Kremlin-Bicêtre, 94270, France

  • AP-HP - hôpital Henri-Mondor

    Créteil, 94010, France

  • AP-HP - hôpital européen Georges-Pompidou

    Paris, 75015, France

  • Antonius hospital

    Sneek, Netherlands

  • Augustinerinnen Hospital

    Cologne, 50678, Germany

  • Azienda Ospedaliera Careggi - Firenze

    Florence, 50134, Italy

  • Bucuresti - Spitalul Clinic de Urgenta Sf. Pantelimon

    Bucharest, Romania

  • CHU Liège

    Liège, 4000, Belgium

  • CHU d'Angers

    Angers, 49933, France

  • CHU de Besançon - Hôpital Jean-Minjoz

    Besançon, 25030, France

  • CHU de Brest - Hôpital de la Cavale Blanche

    Brest, 29000, France

  • CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • CHU de Grenoble - Hôpital Michallon

    La Tronche, 38700, France

  • CHU de Nice - Hôpital Pasteur

    Nice, 06000, France

  • CHU de Saint-Étienne - Hôpital Nord

    Saint-Etienne, 42055, France

  • CHU de Strasbourg - Hôpital Civil

    Strasbourg, 67000, France

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31000, France

  • CHU de Tours - Hôpital Trousseau

    Chambray-lès-Tours, 37170, France

  • Cardiology Clinic, Clinical Center of Niš

    Niš, Serbia

  • Cardiology Clinic, Emergency Center, Clinical Center of Serbia

    Belgrade, Serbia

  • Catharina hospital

    Eindhoven, Netherlands

  • Centro Hospitalar de Lisboa Norte/ Hospitalde Santa Maria

    Lisbon, Portugal

  • Centro Hospitalar de Lisboa Ocidental

    Lisbon, Portugal

  • Centro Hospitalar de Setubal

    Setúbal, Portugal

  • Centro Hospitalar do Porto

    Porto, Portugal

  • Cologne Universität Herzzentrum

    Cologne, 50937, Germany

  • DRK Kliniken Berlin Köpenick

    Berlin, 10117, Germany

  • Dresden, Städtisches Klinikum

    Dresden, 01067, Germany

  • Düsseldorf, Augusta-Krankenhaus

    Düsseldorf, 40472, Germany

  • Foothills Medical Centre

    Calgary, Alberta, Canada

  • Freiburg Universität

    Freiburg im Breisgau, 79085, Germany

  • Geneva University Hospital

    Geneva, 1205, Switzerland

  • Greifswald, Univ.-Medizin

    Greifswald, 17489, Germany

  • HCL - Centre Hospitalier Lyon-Sud, Pierre-Bénite

    Lyon, 69495, France

  • HCL - Hôpital Edouard Herriot

    Lyon, 69000, France

  • Haaglanden hospital

    The Hague, Netherlands

  • Hamilton General Hospital - Hamilton Health Sciences Corporation

    Hamilton, Ontario, Canada

  • Hannover, Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Hospital Bellvitge

    Barcelona, 08907, Spain

  • Hospital Cartagena

    Cartagena, Spain

  • Hospital Clinic

    Barcelona, 08036, Spain

  • Hospital Galdakao

    Galdakao, 48960, Spain

  • Hospital Garcia de Orta

    Almada, Portugal

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital La Fe

    Valencia, 46026, Spain

  • Hospital Pedro Hispano

    Matosinhos Municipality, Portugal

  • Hospital Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Virgen del Rocío

    Seville, 41013, Spain

  • Humanitas Hospital - Milano

    Milan, 20089, Italy

  • Hôpital du Valais

    Sion, 1951, Switzerland

  • Iasi - St Spiridon Emergency Conty Hospital

    Iași, 700111, Romania

  • Institute for Lung Diseases of Vojvodina, Sremska Kamenica

    Novi Sad, Serbia

  • Institutul de Boli Cardio-Vasculare Timisoara

    Timișoara, Romania

  • Isala hospital

    Zwolle, Netherlands

  • Jewish General Hospital

    Montreal, Quebec, Canada

  • Juravinski Hospital - Hamilton Health Sciences Corporation

    Hamilton, Ontario, ON L8V 1C3, Canada

  • KU Leuven

    Leuven, 3000, Belgium

  • Kingston Health Sciences Centre

    Kingston, Ontario, Canada

  • Leipzig, Univ.-Klinikum

    Leipzig, 4103, Germany

  • London Health Sciences Centre

    London, Ontario, Canada

  • Maasstad hospital

    Rotterdam, Netherlands

  • Mainz Universitätsmedizin, CTH

    Mainz, 55131, Germany

  • Mainz, Katholisches Klinikum

    Mainz, 55131, Germany

  • Martini hospital

    Groningen, Netherlands

  • Medical University of Bialystok

    Bialystok, Poland

  • Medisch Spectrum Twente

    Enschede, Netherlands

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020, Austria

  • Ospedale Ca Foncello - Treviso

    Treviso, 31100, Italy

  • Ospedale San Giuseppe - Empoli

    Empoli, 50053, Italy

  • Spedali Riuniti - Cremona

    Cremona, 26100, Italy

  • Spitalul Judetean de Urgenta Baia Mare

    Baia Mare, 430031, Romania

  • Spitalul Judetean de Urgenta Constanta

    Constanța, 900591, Romania

  • The Ottawa Hopsital, General and Civic campuses

    Ottawa, Ontario, Canada

  • Tübingen, Univ.-Klinikum

    Tübingen, 72076, Germany

  • UCL Brussels

    Brussels, Belgium

  • Ulm, Universitätsklinikum

    Ulm, 89081, Germany

  • University Hospital Ancona / Ospedali Riunit

    Ancona, 60020, Italy

  • University Medical Centre Ljubljana

    Ljubljana, 1000, Slovenia

  • University of Perugia

    Perugia, 06123, Italy

  • University of Warmia Mazury in Olsztyn - School of Medicine

    Olsztyn, 11-041, Poland

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, 79189, Germany

  • Universitätsmedizin Mannheim UMM

    Mannheim, 68167, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.