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Study on Blood Pressure Management with Urapidil, Phenylephrine, and Labetalol for Patients with Acute Ischemic Stroke After Endovascular Therapy

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 clinical trial is focused on studying the treatment of Acute Ischemic Stroke, a condition where blood flow to a part of the brain is blocked, often leading to brain damage. The study involves patients who have undergone a procedure called mechanical thrombectomy, which is used to remove the blockage from a large blood vessel in the brain. The trial aims to compare the benefits of standard blood pressure management after this procedure with a new approach that adjusts blood pressure targets based on how well the blood flow is restored during the procedure.

The study will use three different medications: Urapidil, Phenylephrine Hydrochloride, and Labetalol Hydrochloride. These medications are administered intravenously, meaning they are given directly into a vein. Urapidil is used to lower blood pressure by relaxing blood vessels, Phenylephrine Hydrochloride is a cardiac stimulant that helps increase blood pressure, and Labetalol Hydrochloride works by blocking certain receptors in the body to lower blood pressure. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual medications.

The purpose of the study is to determine which method of blood pressure management provides the most benefit to patients after a stroke. Participants will be monitored for a period of up to three days, during which their blood pressure will be managed according to the assigned protocol. The study will assess the outcomes at 90 days after the treatment to see if there is an improvement in the patients' recovery and overall health. This research aims to improve the treatment and recovery process for individuals who have experienced an acute ischemic stroke.

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 experiencing an acute ischemic stroke and undergoing a procedure called mechanical thrombectomy. This procedure is used to remove a blood clot from a large blood vessel in the brain.

    Eligibility requires successful recanalization, which means the blood flow has been restored to a certain degree, measured by a TICI score of 2b, 2c, or 3. Additionally, a prior score on the modified Rankin Scale (mRS) of 0, 1, or 2 is necessary. Consent must be provided either in writing or verbally.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups. One group receives standard blood pressure management, while the other follows a specific protocol aimed at optimizing blood flow to the brain based on the degree of recanalization achieved during the procedure.

  3. Step 3

    Treatment administration

    The treatment involves the use of medications administered intravenously. These medications include urapidil, phenylephrine hydrochloride, and labetalol hydrochloride. Each medication is provided as a solution for injection or infusion.

    The dosage and frequency of administration are determined by the specific protocol assigned to the participant.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for changes in their condition, with a focus on blood pressure management and overall recovery.

    The primary outcome is assessed by comparing the modified Rankin Scale (mRS) score at 90 days after randomization. This score helps evaluate the level of disability or dependence in daily activities.

  5. Step 5

    Completion of the study

    The study is expected to conclude by September 1, 2025. Participants' progress and outcomes are analyzed to determine the effectiveness of the treatment protocols.

Who can join the trial?

7 criteria

  • The patient must have had an acute ischemic stroke, which is a type of stroke caused by a blockage in a blood vessel in the brain.
  • The stroke must involve a blockage in a large blood vessel in the brain and must have occurred within 24 hours before treatment.
  • The patient must have undergone a procedure called mechanical thrombectomy, which is a treatment to remove the blockage from the blood vessel.
  • The procedure must have been successful, which is measured by a TICI score of 2b, 2c, or 3. The TICI score is a way to describe how well blood flow has been restored in the brain.
  • The patient must have had a score of 0, 1, or 2 on the modified Rankin Scale (mRS) before the stroke. The mRS is a scale that measures the level of disability or dependence in daily activities.
  • The patient or their legal representative must provide informed consent, which means they agree to participate in the study after understanding what it involves. This can be given in writing or verbally.
  • The study is open to both male and female patients.

Who cannot join the trial?

6 criteria

  • Patients who have a medical condition other than Acute Ischemic Stroke may not be eligible. Acute Ischemic Stroke is a condition where blood flow to a part of the brain is blocked, causing brain cells to be damaged or die.
  • Patients who are not within the specified age range for the study may be excluded. The age range is typically defined by the study and can vary.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or have certain disabilities, may not be eligible.
  • Patients who do not meet the specific health criteria set by the study, such as blood pressure levels or other health markers, may be excluded.
  • Patients who have had certain medical procedures or treatments that are not compatible with the study's requirements may not be eligible.
  • Patients who are unable to follow the study protocol or attend required visits may be excluded.
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Investigated drugs

  • Standard Blood Pressure Management

    is a common approach used after mechanical thrombectomy, a procedure to remove a blood clot from a blood vessel in the brain. This method involves maintaining blood pressure within a typical range to ensure stable blood flow to the brain, helping to prevent further complications after a stroke.

  • Hemodynamic Optimization Protocol

    is a specialized approach that adjusts blood pressure targets based on how well blood flow is restored during the mechanical thrombectomy. This protocol aims to optimize blood flow to the brain by tailoring blood pressure management to the individual needs of the patient, potentially improving recovery outcomes after a stroke.

What is already known about the treatment

Hemodynamic Optimization Protocol – This protocol is administered through a specific blood pressure management strategy following mechanical thrombectomy in patients with acute ischemic stroke. It is currently being evaluated in clinical trials to determine its effectiveness compared to standard blood pressure management. The main therapeutic indication is to improve cerebral perfusion after endovascular therapy in stroke patients. The mechanism of action involves adjusting blood pressure targets based on the degree of blood vessel recanalization achieved during the procedure, aiming to optimize blood flow to the brain. It falls under the pharmacological classification of hemodynamic management strategies.

Investigated diseases

Acute Ischemic Stroke – This condition occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. The lack of oxygen causes brain cells to begin dying within minutes, leading to potential brain damage. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of the disease can vary, with some individuals experiencing rapid improvement, while others may have lasting impairments. The severity and specific symptoms depend on the location and extent of the blockage in the brain. Immediate medical attention is crucial to minimize brain damage and improve outcomes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516642-19-01Protocol codeIIBSP-HOP-2021-01Estimated enrolment814 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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