Study on the Safety and Effectiveness of Tenecteplase for Patients with Acute Ischemic Stroke and Incomplete Reperfusion After Mechanical Thrombectomy

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a treatment for acute ischemic stroke, a condition where blood flow to the brain is blocked, often by a clot. The treatment being tested is called Tenecteplase, also known by its code name TNK-TPA. This medication is administered directly into the arteries to help dissolve clots in patients who have experienced a stroke due to a blockage in a large blood vessel, and who have not achieved complete blood flow restoration after a procedure called mechanical thrombectomy.

The purpose of the study is to determine how safe and effective Tenecteplase is for patients with this type of stroke. Participants in the study will receive either the medication or a placebo. The study will monitor the early and late restoration of blood flow in the brain, as well as the degree of disability or dependence after 90 days. Other aspects being observed include changes in stroke severity, quality of life, and overall survival at 90 days.

The study will follow participants over a period of time to assess these outcomes. The goal is to gather information that could help improve treatment options for people who experience an acute ischemic stroke with incomplete blood flow restoration after initial treatment. This research is important for understanding how to better manage and treat this serious condition.

1 joining the study

Upon joining the study, informed consent is required. This means understanding the study’s purpose, procedures, and potential risks and benefits before agreeing to participate.

Eligibility criteria include being at least 18 years old and experiencing clinical signs consistent with an acute ischemic stroke.

2 initial assessment

An initial assessment will be conducted to confirm the presence of a large vessel blockage in the brain’s anterior circulation. This includes specific areas such as the intracranial ICA, M1, M2, M3, A1, A2, P1, or P2.

The assessment will also confirm that the patient has undergone a procedure called endovascular stroke treatment.

3 randomization

Randomization will occur within 705 minutes (11 hours and 45 minutes) after the onset of stroke symptoms or the last time the patient was known to be well.

This step involves being randomly assigned to receive the study treatment or a standard treatment.

4 treatment administration

The study treatment involves the administration of tenecteplase, a medication given through intra-arterial use. This means it is delivered directly into the artery.

The medication is provided as a solution for injection, specifically Metalyse 10,000 units.

5 monitoring and follow-up

After treatment, monitoring will occur to assess early and late reperfusion, which refers to the restoration of blood flow in the brain.

Follow-up assessments will be conducted to evaluate the degree of disability or dependence at approximately 90 days, using a scale called the mRS.

Additional evaluations include changes in the NIHSS, a scale that measures stroke severity, at 24 hours and 90 days post-randomization.

Quality of life will be assessed using the EuroQol 5D-3L questionnaire at 90 days, and all-cause mortality will be recorded at 90 days.

Who Can Join the Study?

  • Provide informed consent, which means you agree to participate after understanding the study details.
  • Be at least 18 years old.
  • Show clinical signs that match an acute ischemic stroke, which is a type of stroke caused by a blockage in a blood vessel in the brain.
  • Have had an initial blockage in a large blood vessel in the front part of the brain, specifically in areas called intracranial ICA, M1, M2, M3, A1, A2, P1, or P2.
  • Have undergone a procedure called endovascular stroke treatment, which is a treatment to remove the blockage in the blood vessel.
  • Be randomized to the study within 705 minutes (11 hours and 45 minutes) after the stroke symptoms started or were last known to be well.
  • Have incomplete reperfusion, meaning the blood flow was not fully restored after treatment. This is defined as:
    • For ICA/M1: TICI2b/2c (50-99%) reperfusion after treatment without a blockage that can be fixed mechanically.
    • For A1/A2, P1/P2, M2/M3: TICI2a/2b/2c (1-99%) reperfusion after treatment without a blockage that can be fixed mechanically.
    • Any new blockages in other areas without a blockage that can be fixed mechanically.
  • Show signs of early changes in the brain due to the stroke on a CT scan, with an ASPECTS score of 5 or more. This score helps doctors assess the extent of the stroke.

Who Cannot Join the Study?

  • Patients who have had a recent major surgery or serious injury.
  • Patients with a history of bleeding disorders, which means their blood does not clot properly.
  • Patients who are currently taking blood-thinning medications, which are drugs that prevent blood clots.
  • Patients with uncontrolled high blood pressure, meaning their blood pressure is too high and not managed by medication.
  • Patients who have had a previous stroke within the last three months.
  • Patients with severe liver or kidney disease, which means their liver or kidneys are not working properly.
  • Patients who are pregnant or breastfeeding.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them 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
Universitaetsmedizin Goettingen Goettingen Germany
Centro Hospitalar Universitario Lisboa Central E.P.E. Lisbon Portugal
Universitaet Leipzig Leipzig Germany
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Medizinische Universitaet Innsbruck Innsbruck Austria
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium
Universitätsklinikum Freiburg Freiburg Im Breisgau Germany

Other Sites

Site Name City Country Status
CHC MontLegia Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
HELIOS Klinikum Erfurt GmbH Erfurt Germany
Unidade Local De Saude De Gaia/Espinho E.P.E. Vila Nova De Gaia Portugal
Johannes Wesling Klinikum Minden Minden Germany
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Asklepios Kliniken Hamburg GmbH Hamburg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Kepler Universitaetsklinikum GmbH Linz Austria
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Vrije Universiteit Brussel Jette Belgium
LMU Klinikum Munich Germany
Klinikum Bremen-Mitte gGmbH Bremen Germany
Uniklinikum Salzburg Salzburg Austria
Klinikum rechts der Isar derTechnischen Universität München Munich Germany
Unidade Local de Saúde Lisboa Ocidental (ULSLO) Lisbon Portugal
Mtndqtwnkn Utnehxtlyi Mnrzciz Cdzcvq Maastricht The Netherlands
Ajaquxyhu Unh Amsterdam The Netherlands
Hqarabqr Uotmpfwmgs Cuprsaz Hnwxefrs Helsinki Finland
Cmeqbxuon Uthbvtstxbephy Sgxdmbsdm Woluwe-Saint-Lambert Belgium
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Mtqdkgg Ucksznzcvc Og Gpep Graz Austria
Cngwkg Hvbzkospvx E Uoscfxwzgjgyv Dn Ckyljzu Enjwyg Coimbra Portugal
Uwrmvlgcbmaghmsokgegx Meicfsnn Aqk Munster Germany
Geoybb Umiqtpvoft Fnquybqgj Frankfurt Germany
Cvhkmf Hqxqhfelkp Uzwmdzbsyrcrj Dk Pfdil Edlkny Porto Portugal
Limax Uczigpphkifo Mltknef Cuwelxb (vuged Leiden The Netherlands
Sdijigbtvfoe Kogwhmcj Ssbfkenz gewtv Solingen Germany
Mfdlmndiqwvhzyiroywzhbftct Hoelxdhigvszyxah Halle (Saale) Germany
Uhrzfglmndtcftpzdvwfw Atqkdaha Augsburg Germany
Hypwdgngbo Mxjndfp Czyldqs Svcwqknmn Hague The Netherlands
Ubmajodkuy Missaha Cfptot Hxdqeorexowxgkcvi Hamburg Germany

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
01.05.2023
Belgium Belgium
Not recruiting
01.05.2023
Finland Finland
Not recruiting
01.05.2023
Germany Germany
Not recruiting
01.05.2023
Portugal Portugal
Not recruiting
01.05.2023
The Netherlands The Netherlands
Not recruiting
01.05.2023

Trial locations

Investigated drugs:

Tenecteplase is a medication used in this clinical trial to help treat patients who have had a stroke. A stroke can happen when a blood clot blocks a blood vessel in the brain, stopping blood from getting to that part of the brain. This medication is given directly into the arteries to help dissolve the blood clot and improve blood flow. The goal is to see if this medication is safe and effective for patients who have had a stroke and still have some blockage in their brain’s blood vessels even after another procedure called mechanical thrombectomy, which is used to remove clots. By using this medication, doctors hope to improve recovery and outcomes for stroke patients.

Investigated diseases:

Acute Ischemic Stroke – Acute ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, causing a sudden loss of blood flow. This interruption in blood supply results in the deprivation of oxygen and nutrients to brain tissue, leading to the death of brain cells. The progression of the disease can vary, but it often begins with sudden symptoms such as weakness or numbness on one side of the body, confusion, trouble speaking, or difficulty seeing. If the blockage is not quickly resolved, more brain tissue can be affected, potentially leading to more severe neurological deficits. In some cases, partial reperfusion may occur, where blood flow is partially restored, but residual occlusions remain, which can continue to affect brain function. The extent of recovery or progression depends on the location and size of the affected area and the timeliness of medical intervention.

Trial ID:
2022-502878-16-00
NCT ID:
NCT05499832
Trial Phase:
Therapeutic confirmatory (Phase III)

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