Study on Reduced Dose of Alteplase for Patients with Intermediate-High-Risk Acute Pulmonary Embolism

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What is this study about?

This clinical trial is focused on studying a condition known as intermediate-high-risk acute pulmonary embolism. This is a serious condition where a blood clot blocks the blood vessels in the lungs, which can lead to severe health issues. The treatment being tested in this study is a medication called ACTILYSE, which contains the active substance alteplase. This medication is used to help dissolve blood clots and is administered through an injection or infusion into the veins. The study also involves a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to evaluate the effectiveness of a reduced dose of this thrombolytic therapy, which is a treatment that helps break down blood clots, in patients with this type of pulmonary embolism. Participants in the study will receive either the reduced dose of ACTILYSE or a placebo. The study will monitor the participants over a period of 30 days to assess the outcomes, which include the risk of death from any cause, the occurrence of hemodynamic decompensation (a condition where the heart cannot maintain adequate blood flow), or the recurrence of pulmonary embolism.

Throughout the study, researchers will also observe any severe or life-threatening bleeding events and evaluate the overall clinical benefits of the treatment. The study aims to provide valuable insights into whether a lower dose of the medication can effectively treat the condition while minimizing potential side effects. This research is important for improving treatment options for patients with intermediate-high-risk acute pulmonary embolism.

1 joining the study

Participation begins after meeting specific criteria, including being 18 years or older and having a confirmed diagnosis of acute pulmonary embolism (PE) with symptoms starting within the last two weeks.

The condition must be confirmed through specific medical imaging tests, and there must be an elevated risk of early death or complications.

2 randomization

Randomization occurs within 6 hours after confirming certain medical criteria, such as heart function and injury markers.

This process assigns participants to different treatment groups without choice or preference.

3 treatment administration

Participants receive a reduced dose of thrombolytic therapy, specifically using the medication alteplase.

The medication is administered intravenously, meaning it is given directly into a vein.

4 monitoring and follow-up

Participants are monitored for 30 days to assess the treatment’s effectiveness and any potential side effects.

The primary focus is on preventing death, hemodynamic issues, or recurrent PE during this period.

5 evaluation of outcomes

The main outcomes evaluated include survival, the occurrence of severe bleeding, and overall clinical benefit.

These outcomes help determine the success and safety of the treatment.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must have an acute pulmonary embolism (PE) confirmed by tests, with first symptoms appearing 2 weeks or less before joining the study. Confirmation can be through:
    • A lung scan showing a mismatch in air and blood flow in the lungs.
    • A CT scan or special lung X-ray showing a blockage in a lung artery.
  • PE must be confirmed within 24 hours before joining the study.
  • Must have a high risk of early death or serious heart or lung problems, shown by at least one of these:
    • Blood pressure of 110 mm Hg or lower for at least 15 minutes.
    • Temporary need for fluids or low-dose medication to raise blood pressure, but stable within 2 hours and maintaining blood pressure of 90 mm Hg or higher without medication.
    • Breathing rate over 20 breaths per minute or oxygen level below 90% while resting and breathing room air.
    • History of chronic heart failure, diagnosed or treated in the past 12 months.
  • Right heart dysfunction shown by a specific heart measurement (RV/LV diameter ratio greater than 1.0) on an ultrasound or CT scan.
  • High levels of troponin, a heart-related protein, in the blood.
  • Must be able to join the study within 6 hours after the doctor gets the results of the heart tests.
  • Must sign a consent form agreeing to participate.
  • Must be covered by a social security system.

Who Cannot Join the Study?

  • Patients who are not diagnosed with intermediate-high-risk acute pulmonary embolism cannot participate. This condition involves a blockage in the lung’s blood vessels that is considered serious but not the most severe.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Medizinische Hochschule Hannover Hanover Germany
Augustinerinnen Krankenhaeuser gGmbH Cologne Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
University Hospital Of Clermont-Ferrand Clermont Ferrand France
IRCCS Humanitas Research Hospital Rozzano Italy
DRK Kliniken Berlin Berlin Germany
University Medicine Greifswald Greifswald Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Azienda Socio Sanitaria Territoriale Di Cremona Cremona Italy
Hospital Universitario Rio Hortega Valladolid Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Hospital De Galdakao Usansolo Galdakao Spain
Herzzentrum Leipzig GmbH Leipzig Germany
Marienhaus Klinikum Mainz GmbH Mainz Germany
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Universita’ Degli Studi Di Perugia Perugia Italy
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Clinic De Barcelona Barcelona Spain
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Universita’ Politecnica Delle Marche Ancona Italy
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
University Medical Center Ljubljana Ljubljana Slovenia
Staedtisches Klinikum Dresden Dresden Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universitaetsklinikum Leipzig AöR Leipzig Germany
Onxlbunghkfens Lvxm Gqdh Linz Austria
Uhwvmkzjcnxqk Slhdmnz Kkdjfpirh W Ofxeobdul Olsztyn Poland
Ajhizpo Unxp 5 Poyainsm Rovigo Italy
Appzoiueya Puwaenzj Hghrpjew Df Maunfbhye Marseille France
Bmehjsjn Uzeoduutnz Hldlocwl Ciyajy Besançon France
Cqbtnw Hnnhkoqczvi Reifotnv Uzmrqludfvkel Dd Tmkcv Tours France
Cpydej Hycbbyhytwo Rongmoiz Dhtvlfxgdbssao Angers France
Hplgtqkd Ubqqmdnpxzmmd Hkjnyytz Tzopc y Ppkpzi Izmwxrcb Cnqbxv dkxtdgfnerlfmverm (xlwr Badalona Spain
Imxiyiuf dh Ctgjctenpwko Hvvlpnoxhav Uqyacqsruoggp dv Spuge Eutngqd (gvcktdz Saint Priest En Jarez France
Hpwuqgcf Ugnasptrbzggaw Sknsydafxz &jfhcsh Hwscpoo dx Hvtaqkvxlfm STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
04.08.2021
France France
Not recruiting
04.08.2021
Germany Germany
Not recruiting
04.08.2021
Italy Italy
Not recruiting
04.08.2021
Poland Poland
Not recruiting
04.08.2021
Slovenia Slovenia
Not recruiting
04.08.2021
Spain Spain
Not recruiting
04.08.2021
The Netherlands The Netherlands
Not recruiting
04.08.2021

Trial locations

Investigated drugs:

Thrombolytic Therapy is a treatment used to dissolve dangerous clots in blood vessels, improve blood flow, and prevent damage to tissues and organs. In this clinical trial, a reduced dose of thrombolytic therapy is being tested to see if it is effective for patients with intermediate high-risk acute pulmonary embolism. The goal is to determine if this lower dose can still effectively treat the condition while potentially reducing the risk of side effects associated with higher doses.

Investigated diseases:

Acute Pulmonary Embolism – This condition occurs when a blood clot blocks one or more arteries in the lungs. It often originates from clots in the legs, known as deep vein thrombosis, which travel to the lungs. Symptoms can include sudden shortness of breath, chest pain, and coughing, sometimes with blood. The severity of the condition can vary, with intermediate-high-risk cases involving significant strain on the heart and potential for hemodynamic instability. The progression of the disease can lead to complications such as reduced oxygen levels in the blood and damage to lung tissue. Early recognition and management are crucial to prevent further complications.

Trial ID:
2024-511321-54-00
Protocol code:
P160924
NCT ID:
NCT04430569
Trial Phase:
Therapeutic confirmatory (Phase III)

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