A study to evaluate the effectiveness of tenecteplase in patients with acute ischemic stroke who are more than 4.5 hours after their last known well time.

3 1 1 1

What is this study about?

This study focuses on Acute Ischemic Stroke, a condition that occurs when a blood vessel supplying the brain becomes blocked, preventing oxygen from reaching brain cells. The research aims to evaluate the effectiveness and safety of tenecteplase compared to the current standard medical treatments. This study is specifically looking at individuals who were last seen well more than 4.5 hours before receiving treatment, including cases known as wake-up stroke, where the exact time the symptoms started is unknown. This group includes people who show evidence through imaging, such as a computed tomography scan, that there is still salvageable brain tissue that can be saved if blood flow is restored.

During the trial, participants will receive either tenecteplase or the standard of care via an intravenous bolus, which is a method of delivering medication directly into a vein in a single quick dose. The study will monitor how well patients recover and function over a period of time, specifically looking at their ability to perform daily activities 90 days after the event. The researchers will also observe for any potential side effects, such as symptomatic intracranial hemorrhage, which is a type of bleeding inside the brain that can occur following treatment.

Who Can Join the Study?

  • You must be a man or a woman who is at least 18 years old, or the legal age of adulthood in your country.
  • You must provide a signed and dated consent form, which is a written document where you agree to take part in the study.
  • You must have had an acute ischaemic stroke, which is a sudden blockage of blood flow to part of the brain that causes brain cells to die.
  • The stroke must be a wake-up stroke, which means the stroke happened while you were sleeping and was only discovered when you woke up.
  • The stroke must affect the supratentorial circulation, which refers to the upper part of the brain.
  • The time since you were last known to be healthy must be more than 4.5 hours before you are assigned to a treatment group.
  • Before the stroke, you must have had a modified Rankin Scale (mRS) score of 1 or less, which means you were able to function well and perform daily activities without significant help.
  • You must meet specific requirements based on imaging, which means doctors must see certain results on your MRI (a detailed scan using magnets) or CT scan (a scan using X-rays) to ensure you can participate.

Who Cannot Join the Study?

  • You cannot participate if you plan to undergo mechanical thrombectomy, which is a surgical procedure to remove a blood clot, at the same hospital where you start the study.
  • You are excluded if you have a history of damage to the central nervous system, which is the part of the body consisting of the brain and spinal cord, such as a neoplasm (a tumor or abnormal growth), an aneurysm (a weak or bulging spot in an artery wall), or malformations (abnormal developments) of the blood vessels.
  • You cannot join if you have had previous surgery on your brain or spine.
  • You are excluded if you have other medical conditions or health issues that increase your risk of bleeding outside of the brain.
  • You cannot participate if you have any medical reasons why you are not allowed to take tenecteplase, which is a medicine used to dissolve blood clots.
  • You are excluded if you have a blockage in the internal carotid artery, which is one of the main large blood vessels in the neck that supplies blood to the brain.
  • You cannot join if you are considered a high-risk patient, meaning you have a greater chance of experiencing a hemorrhage, which is bleeding inside the body, as a result of the treatment.
  • You are excluded if any scans of your brain, such as a non-contrast CT scan (an X-ray of the brain without special dye) or an MRI (a detailed image using magnets), show any signs of bleeding in the brain.
  • You cannot participate if you are unable to undergo brain imaging that uses contrast, which is a special dye used to make blood vessels and tissues easier to see on scans.
  • You are excluded if your stroke is considered severe based on a clinical scale called the NIHSS, which is a tool used by doctors to measure the seriousness of stroke symptoms.
  • You cannot join if your stroke symptoms are minor and do not cause significant disability, or if your symptoms are improving very quickly.
  • You are excluded if your brain scans or physical symptoms do not show an acute ischemic stroke, which is a stroke caused by a sudden blockage of blood flow to the brain, or if they suggest the stroke happened more than 72 hours ago.
  • You cannot participate if you are already scheduled to receive intravenous thrombolysis, which is the standard medical treatment of using medicine through a vein to break up a clot.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Kistarcsai Flor Ferenc Korhaz Kistarcsa Hungary
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Helse Stavanger HF Stavanger Norway
Athens Euroclinic S.A. Athens Greece
University Multiprofile Hospital For Active Treatment Kaspela EOOD Plovdiv Bulgaria
Athens Naval Hospital Athens Greece
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava Suceava Romania
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
UMHAT “Medica Ruse” OOD Ruse Bulgaria
Semmelweis University Budapest Hungary
Hospital Universitario De Cruces Barakaldo Spain
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Sykehuset Oestfold HF Kalnes Graalum Norway
General University Hospital Of Patras Patras Greece
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Hospital Ruber Juan Bravo Madrid Spain
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Eginitio Hospital Athens Greece
University Of Pecs Pecs Hungary
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
University Of Szeged Szeged Hungary
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Hospital Alvaro Cunqueiro Vigo Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Hospital Universitari Joan XXIII De Tarragona Tarragona Spain
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Mbutqskuiuoahpasj Hqkmfezj Frc Apzrpm Tbndcodss Cjqf Cnrenq Snzim Gdaxee Lov Montana Bulgaria
Strefqqzbb Jnxvewot Dk Urxqvkz Pdkcim Nzfag Piatra-Neamt Romania
Ssgxrqfr Clknqx Jrgckqlz Dt Ufczoum Bkowqt Brasov Romania
Duqjdnsyem Cntoetsqzisd Cmzdas (qopr &yzwjspetrdt Aczhdrynvjg Ewpd Sofia Bulgaria
Hewleqlv Dr Li Sqnmj Chxp I Sgvi Plc Barcelona Spain
Hrhtgnea Umfzmvqanthid Hogahsnw Tteua y Pjrtny Imlncosr Ctblfq diunduyiacpqcjsur (fdwy Badalona Spain
Hvijhgci Vruw dzfuibss Barcelona Spain
Hdbgsonk Uetwbgobkuagj dx A Ckredk A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not yet recruiting
26.03.2026
Greece Greece
Not yet recruiting
26.03.2026
Hungary Hungary
Not yet recruiting
26.03.2026
Norway Norway
Not yet recruiting
26.03.2026
Romania Romania
Not yet recruiting
26.03.2026
Spain Spain
Not yet recruiting
26.03.2026

Trial locations

Investigated drugs:

Tenecteplase is a medication given through a vein that is used to help dissolve blood clots in the brain to help restore blood flow during an acute ischemic stroke.

Investigated diseases:

Acute Ischemic Stroke – This condition occurs when a blood vessel supplying blood to the brain becomes blocked by a clot. The lack of blood flow prevents oxygen and nutrients from reaching brain cells. As a result, the affected brain cells begin to suffer damage and may die. The symptoms can appear suddenly depending on which part of the brain is affected. The progression of the damage is often linked to how quickly the blood flow is restored.

Trial ID:
2025-522542-40-00
Protocol code:
1123-0060
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A Study of TGD001 in Patients with Acute Ischemic Stroke to Test Safety and Effectiveness

    Recruiting

    1 1 1
    Germany Poland Spain
  • A study testing tenecteplase given directly into the artery after blood clot removal in patients with acute ischemic stroke in the front part of the brain

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Germany