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Study of intra-arterial alteplase (t-PA) during mechanical thrombectomy treatment in patients with acute ischemic stroke caused by large vessel blockage

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study focuses on patients with acute ischemic stroke, a condition where blood flow to the brain is blocked by a clot in one of the major blood vessels. The study examines the effectiveness of using alteplase (also known as t-PA), a clot-dissolving medication, during a procedure called mechanical thrombectomy where doctors physically remove the blood clot that is blocking blood flow to the brain.

The purpose of this research is to determine whether giving alteplase directly into the affected artery during mechanical thrombectomy can improve outcomes for stroke patients. The medication will be given through intraarterial injection, which means it is delivered directly into the blocked blood vessel while doctors are removing the clot.

During the study, participants will receive the standard mechanical thrombectomy procedure to remove the blood clot, with some patients also receiving alteplase through the artery. The treatment is given as a single dose during the procedure, and patients will be monitored afterward to assess their recovery from the stroke. The study will track how well patients recover their ability to perform daily activities and whether they experience any complications.

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

    Initial assessment

    Your eligibility for the study will be evaluated if you have experienced an acute ischemic stroke affecting large blood vessels in the brain

    You must be at least 18 years old and have significant stroke symptoms with a specific severity score of 6 or higher

    Brain imaging will be performed to confirm the location of the blood clot and measure the affected brain tissue

  2. Step 2

    Treatment procedure

    The procedure must begin within 9 hours from the start of stroke symptoms

    You will receive mechanical thrombectomy - a procedure to remove the blood clot from your brain

    During the procedure, you may receive Actilyse (alteplase) medication directly into the affected artery

  3. Step 3

    Monitoring period - first 48 hours

    Your condition will be closely monitored for the first 24-48 hours after the procedure

    A brain scan will be performed to check for any bleeding complications

    Your kidney function will be monitored to check for any effects of the contrast dye used during the procedure

  4. Step 4

    Recovery assessment

    Your recovery progress will be evaluated using specific medical scales

    The medical team will assess your ability to perform daily activities

    Your overall recovery and any complications will be documented

  5. Step 5

    Final evaluation

    The medical team will determine if you can be discharged home, with or without additional support services

    Your final recovery status will be assessed using standardized scales

    Any complications or adverse events during the study period will be recorded

Who can join the trial?

10 criteria

  • Must be able to provide informed consent by signature or oral consent followed by signature
  • Must be at least 18 years old
  • Must have a significant neurological deficit with a NIHSS score of 6 or higher (NIHSS is a scale that measures stroke severity)
  • Must have been independent in daily activities before the stroke (modified Rankin Scale score of 1 or less)
  • Must be eligible for blood vessel treatment (endovascular treatment)
  • Must arrive within 9 hours of stroke symptoms starting, or if symptoms were noticed upon waking up, the time will be calculated from the midpoint between going to sleep and waking up
  • Must have a complete blockage in either the internal carotid artery or middle cerebral artery (main blood vessels in the brain) that can be treated with mechanical removal
  • Must have an area of brain damage that is 70 milliliters or less in size, as measured by special brain scans
  • Must have an area of brain tissue that could potentially be saved (called penumbra), which is at least 20% larger than the damaged area and differs by at least 10 milliliters in size
  • If coming from another hospital, the clot-dissolving medication (tPA) must have been completed at least 40 minutes before a confirming CT scan

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 85 years
  • Pregnancy or breastfeeding women
  • Previous stroke in the last 3 months
  • Active internal bleeding
  • Known bleeding disorder or blood clotting problems
  • Use of blood thinners (anticoagulant medications) in the past 48 hours
  • Severe head trauma or brain surgery in the past 3 months
  • Current brain tumor or known brain abnormalities
  • Blood pressure above 185/110 mmHg that cannot be controlled with medication
  • Blood sugar level below 50 mg/dL or above 400 mg/dL
  • Major surgery in the past 14 days
  • Current participation in other clinical trials
  • Unable to provide informed consent (either directly or through a legal representative)
  • Life expectancy less than 90 days due to other medical conditions
  • Severe kidney or liver disease
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Investigated drugs

Tissue Plasminogen Activator (tPA) is a medication that helps dissolve blood clots. In this trial, it is administered directly into the arteries during mechanical thrombectomy. It works by converting plasminogen to plasmin, which breaks down blood clots that are blocking blood flow to the brain during an acute stroke. Mechanical thrombectomy is not a medication but a surgical procedure where doctors use special devices to physically remove blood clots from blocked arteries in the brain. This procedure is performed by threading a catheter through blood vessels to reach and remove the clot that is causing the stroke.

What is already known about the treatment

Tissue Plasminogen Activator (tPA) – A clot-dissolving medication administered through intra-arterial infusion during mechanical thrombectomy procedures for treating acute ischemic stroke. This enzyme-based medication works by breaking down blood clots by activating plasminogen to plasmin, which helps restore blood flow to the brain in patients with large vessel occlusion of the anterior circulation. tPA belongs to the thrombolytic (clot-busting) class of medications and is considered a standard treatment option in acute stroke care when administered within a specific time window after symptom onset. The medication's effectiveness in combination with mechanical thrombectomy is currently being studied in clinical trials to potentially improve outcomes for stroke patients.

Investigated diseases

Acute Ischemic Stroke - A condition that occurs when blood flow to the brain is suddenly blocked by a clot in one of the large blood vessels of the anterior (front) part of the brain. This blockage prevents oxygen and nutrients from reaching brain tissue, leading to the death of brain cells in the affected area. The condition typically develops suddenly and causes symptoms such as weakness or paralysis on one side of the body, difficulty speaking, and facial drooping. Acute ischemic stroke specifically involving large vessel occlusion affects the major arteries of the brain, potentially impacting a significant portion of brain tissue. The severity of symptoms depends on which area of the brain is affected and how long the blockage persists.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510374-13-00Protocol codeVanish TrialEstimated enrolment120 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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