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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Hospital Del Mar Barcelona Spain
Hospital Universitari Joan XXIII De Tarragona Tarragona Spain
Hospital Universitario Central De Asturias Oviedo Spain
Hospital General Universitario De Alicante Alicante Spain
Hospital Clinico Universitario De Valencia Valencia Spain
Hospital Unviersitario Miguel Servet Zaragoza Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Universitario De Cruces Barakaldo Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
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Hhxkjhrv Df Lf Slcce Cdfh I Soam Pie Barcelona Spain

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

Trial status

Country Status Recruitment Start
Spain Spain
Not recruiting
01.04.2021

Trial locations

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.

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 ID:
2024-516642-19-01
Protocol code:
IIBSP-HOP-2021-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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