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
IRCCS Humanitas Research Hospital Rozzano Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Oncopole Claudius Regaud Toulouse France
Medizinische Hochschule Hannover Hanover 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
CHU Grenoble Alpes La Tronche France
DRK Kliniken Berlin Berlin Germany
University Medicine Greifswald Greifswald Germany
Augustinerinnen Krankenhaeuser gGmbH Cologne Germany

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
University Medical Center Ljubljana Ljubljana Slovenia
Ktqpunvm Nukkgscla Nürnberg Germany
Vmrjtt dze Rguuq Ucbynrpmcs Hopvlmxw Sevilla Spain
Uakgjdlcnelyrwcxpzquv Thfgwcdty Amf Tuebingen Germany
Akfiblfxmi Pcejbbyg Hlqyvvxu Dk Mxmteyxsy Marseille France
Hwiymntx Csxcof Dt Bofndutkb Barcelona Spain
Shojgbvwk Rpzxzfx Uqmppcvptf Mvcpdmg Cvmsdl Nijmegen The Netherlands
Ckxgju Hslqhlkofsc Rowyrapq Uonpzrhemtfqd Dm Tifgm Tours France
Uluaaxyxydgqtcmxv Pgfaisukjjc Dwezq Mzdbgi Ancona Italy
Ufmgxwprlwjlszumrsnqu Hxecmimdyk Ako Heidelberg Germany
Msnvuwe Cdqbfs &azplmz Udkiifooam Oi Fdowosgw Freiburg Im Breisgau Germany
Orjovycyxhcuiz Lhxf Gzxo Linz Austria
Cnskjl Huxxpzaixht Llbg Stv Pierre Benite France
Couvcv Hskmcjljggg Rmumxdeb Dpujoatcrqifnu Angers France
Hsodenis Umiobqtffzcdj Ren Hozwemk Valladolid Spain
Ajuoumu Sxvvz Sdwpruvjc Tmfqmpalqcnk Ddl Sijti Lwjew Varese Italy
Ufxkstchdovwiqpclexym Lxftrqa Adv Leipzig Germany
Hqdgqldn Upsznbsmpysmym Sffyriunai &xizaml Hyznigg dy Hgbtqqqdudi STRASBOURG, Alsace France
Umjhshfpvaxuw Smtemag Kxxvyjbkv W Bewccglppjc Bialystok Poland
Ayolmyk Usjt 5 Prhzpkpt Rovigo Italy
Iqhmeapl dk Cmjyvjvwktvl Hvzpggzwxdu Uwapjmkihqudi dh Srnbu Eefxhrc (tfgoawc Saint Priest En Jarez France
Uohrfmengvhjj Symcyou Kqawqqytf W Oslpdrtkq Olsztyn Poland
Mtsjclja Zgucqjjqgg Sdgdhlkzs Rotterdam The Netherlands
Bduqmulb Uuxrrhlexh Hbodpxkq Cglbhb Besançon France
Shfowvvplyac Kaflohrd Dcigegj Dresden Germany
Aacleop Sbjbu Sqcgpaxjy Tlmpsxmbpypq Dg Cbfcepb Cremona Italy
Akqnvfp Uwoknrltozta Ljvatl Sntmk Snytoapvo Ny 2 Mqsuy Tokdpiylov Treviso Italy
Uakxcxbjblimyeovr Dbshz Scbxw Dk Pquexix Perugia Italy
Hzdmawkhhtv Lwpkxrk Gkis Leipzig Germany
Uoontjjjvkcmvt Cogluev Kzxlyhmlk Woysbbkvwthrs Uvjqdopgytcv Mxyjhrztnz Warsaw Poland
Hevemfgo Ds Gaciyouw Uzqlodqz Galdakao Spain
Msoubipllk Khsgafjc Mrzdf Gtax Mainz Germany
Hqsebrwp Uyyicrkrryddq Hudpywvc Tzvkk y Pliode Ixmoumuy Cxrrvc dmbxxtihivwtbftot (sraz Badalona Spain

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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