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Study on Tenecteplase and Alteplase for Patients with Acute Ischemic Stroke Due to Basilar Artery Blockage

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as acute ischemic stroke, which occurs when a blood clot blocks a blood vessel in the brain, leading to reduced blood flow and potential brain damage. Specifically, the study is looking at strokes caused by a blockage in the basilar artery, a major artery at the base of the brain. The trial will compare two treatments: Tenecteplase and Alteplase. Both are medications that help dissolve blood clots, but they are used in different ways and timeframes. Tenecteplase is given within 24 hours of stroke symptoms, while Alteplase is administered within 4.5 hours.

The purpose of the study is to determine if Tenecteplase is more effective than Alteplase or standard care in helping patients recover better from a stroke. Participants in the study will receive either Tenecteplase or Alteplase, or they may receive standard care, which could include no medication. Some patients may also undergo a procedure called thrombectomy, which involves physically removing the clot from the blood vessel. The study will monitor patients for up to 90 days to assess their recovery and overall health outcomes.

Throughout the study, researchers will evaluate the patients' recovery using a scale called the Modified Rankin Scale (mRS), which measures the level of disability or dependence in daily activities. The goal is to see if patients can return to their normal activities or have minimal disability after treatment. The study will also look at other factors, such as early improvement in stroke symptoms and any complications that may arise. The findings from this study could help improve treatment options for patients experiencing a stroke due to basilar artery blockage.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including age 18 or older and experiencing symptoms of a stroke due to basilar artery blockage within 24 hours.

    Consent is required, either from the participant or a representative if the participant is unable to provide it.

  2. Step 2

    Initial assessment

    A medical evaluation is conducted to confirm the presence of a basilar artery blockage using imaging techniques like CT or MR Angiography.

    The participant's ability to function independently is assessed using the modified Rankin Scale (mRS).

  3. Step 3

    Treatment administration

    Participants receive either tenecteplase or alteplase based on the study group assignment.

    Tenecteplase is administered at a dose of 0.25 mg per kg of body weight within 24 hours of symptom onset.

    Alteplase is administered at a dose of 0.9 mg per kg of body weight within 4.5 hours of stroke onset.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for early clinical improvement and any adverse effects, such as bleeding, within 36 hours of treatment.

    Functional outcomes are assessed at 3 months using the modified Rankin Scale to determine the level of disability or return to baseline function.

  5. Step 5

    Long-term evaluation

    Quality of life is assessed at 3 and 12 months using a standardized questionnaire.

    The study aims to determine the proportion of participants achieving no disability or returning to their baseline level of function at 3 months.

Who can join the trial?

6 criteria

  • Must be **18 years or older**.
  • Must have symptoms of a **posterior circulation ischaemic stroke** due to partial or complete blockage of the **basilar artery** within 24 hours from when symptoms started or when the patient was last known to be well. This includes cases where the patient has worsened or is in a coma.
  • Must have a **basilar artery occlusion** (blockage) visible on a **CT Angiography** or **MR Angiography**. This means the blockage can potentially be treated. It can be a partial or complete blockage.
  • Must have a **premorbid mRS ≤3**, which means the patient was able to function independently or needed only minor help at home and could manage alone for at least one week before the stroke.
  • Must be affiliated with a **French social security scheme** or an equivalent system.
  • Must provide **written informed consent** to participate. If the patient cannot give consent, a next of kin or trusted person can do so. If no one is available, an emergency procedure can be used. Once the patient is able, they will be asked to give consent to continue in the study.

Who cannot join the trial?

9 criteria

  • 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 help prevent blood clots.
  • Patients with severe liver or kidney disease, which affects how the body processes substances.
  • Patients who have had a previous stroke caused by bleeding in the brain.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is too high despite treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with a known allergy to the study medication or similar drugs.
  • Patients who have any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

  • Tenecteplase

    This medication is used in the trial to help dissolve blood clots in patients who have had a stroke. It is given within 24 hours after the onset of stroke symptoms. The goal is to improve the patient's recovery by restoring blood flow to the brain.

  • Alteplase

    This is another medication used to break down blood clots in stroke patients. It is typically administered within 4.5 hours of the stroke's onset. The trial compares the effectiveness of alteplase with tenecteplase in improving patient outcomes.

  • Thrombectomy

    This is a medical procedure that involves physically removing a blood clot from a blood vessel in the brain. It is sometimes used in combination with medications like tenecteplase or alteplase to treat strokes caused by blocked arteries. The trial examines the outcomes of using thrombectomy alongside these medications.

What is already known about the treatment

Tenecteplase – This medication is administered intravenously and is currently being studied for its effectiveness in treating acute ischemic stroke caused by basilar artery occlusion. It is in the clinical trial phase, with research focusing on extending the time window for its use. The main therapeutic indication is to improve functional outcomes in stroke patients. Tenecteplase works by breaking down blood clots, as it is a thrombolytic agent that targets fibrin, a protein involved in clot formation. It belongs to the pharmacological class of thrombolytics.

Investigated diseases

Acute Ischemic Stroke Due to Basilar Artery Occlusion – This condition occurs when a blood clot blocks the basilar artery, which supplies blood to critical areas of the brainstem. The blockage leads to a sudden reduction in blood flow, causing brain cells to be deprived of oxygen and nutrients. Symptoms can include sudden dizziness, difficulty speaking, vision problems, and weakness or numbness on one side of the body. As the condition progresses, it can lead to more severe neurological impairments. The severity and progression depend on the size and location of the blockage and the time taken to restore blood flow. Early intervention is crucial to minimize brain damage and improve functional outcomes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513444-28-00Protocol codeDR230297Estimated enrolment120 patientsSponsorCentre Hospitalier Regional Universitaire De Tours

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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