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Study on Mechanical Thrombectomy and Acetylsalicylic Acid for Patients with Acute Ischemic Stroke from Large Vessel Blockage

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Verified & featuredResponsive
Warsaw, Poland
Not yet recruiting

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, which occurs when a blood clot blocks a large blood vessel in the brain, leading to reduced blood flow and potential brain damage. The study will explore the effectiveness of a procedure called mechanical thrombectomy, which involves physically removing the clot from the blood vessel, in combination with standard treatment that includes the use of acetylsalicylic acid (commonly known as aspirin). The goal is to determine if this combined approach is more effective than the standard treatment alone in improving patient outcomes.

Participants in the study will receive either the standard treatment with acetylsalicylic acid or the standard treatment plus mechanical thrombectomy. The study will monitor the participants' recovery and health over a period of 90 days, using a scale called the modified Rankin Scale to assess their functional outcomes, which includes evaluating their ability to perform daily activities and their overall survival. The study will also look at changes in brain imaging results and any potential side effects, such as bleeding in the brain.

The trial aims to provide valuable insights into whether adding mechanical thrombectomy to the standard treatment can offer better recovery prospects for patients who have experienced an acute ischemic stroke due to a large vessel blockage. This research could potentially lead to improved treatment strategies and outcomes for individuals affected by this serious medical condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, informed consent is required. If unable to sign due to severe neurological issues, verbal consent is acceptable with a witness's signature.
Eligibility includes being an adult with an acute ischemic stroke caused by a large vessel blockage, confirmed by specific imaging tests.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the neurological deficit using the NIHSS scale, which measures the severity of stroke symptoms.
Imaging tests such as MRI will be used to identify a specific mismatch pattern, which is a requirement for participation.
Step 3
Treatment allocation
Participants will be randomly assigned to one of two groups: one receiving standard treatment with acetylsalicylic acid and mechanical thrombectomy, and the other receiving only the standard treatment with acetylsalicylic acid.
The standard treatment involves taking acetylsalicylic acid orally, as prescribed by the medical team.
Step 4
Treatment period
The treatment period will involve regular administration of acetylsalicylic acid and, if applicable, undergoing a mechanical thrombectomy procedure.
The medical team will monitor the patient's response to treatment and any side effects.
Step 5
Follow-up assessments
Follow-up assessments will occur at various intervals, including 24 hours, 48 hours, 7 days, and 90 days after treatment begins.
These assessments will include evaluations of neurological function, quality of life, and imaging tests to measure changes in the brain.
Step 6
Final evaluation
A final evaluation will be conducted 90 days after treatment to assess the overall outcome using the modified Rankin Scale, which measures the degree of disability or dependence in daily activities.
The study aims to determine if the combination of treatments is more effective than the standard treatment alone.

Who can join the trial?

9 criteria

Provide informed consent to participate in the study. If a patient cannot sign due to severe symptoms, they can give verbal consent, which must be confirmed by an independent witness.
Be an adult with an acute ischemic stroke caused by a blockage in a large blood vessel in the brain. This must be confirmed by specific imaging tests like angio-CT or angio-MR.
Have a DWI-FLAIR mismatch. This means certain brain scan results show a specific pattern indicating recent stroke activity.
Have a neurological deficit scored between 5 and 18 on the NIHSS scale, which measures the severity of stroke symptoms.
Be over 18 years old.
For patients in Arm A of the study: The time when stroke symptoms started is unknown but must be less than 24 hours since the patient was last symptom-free, or the time from symptom onset to treatment must be between 6 and 24 hours.
For patients in Arm A: Must not meet the criteria for other specific stroke studies called DAWN and DEFUSE-3.
For patients in Arm B: Have a score from 0 to 5 on the ASPECTS scale, which assesses the extent of stroke damage on a brain scan.
For patients in Arm B: The time from the first stroke symptoms to treatment must not exceed 6 hours.

Who cannot join the trial?

10 criteria

Patients who have had a recent **bleeding in the brain** (hemorrhage) cannot participate.
Patients with a **severe allergy** to the study medications are excluded.
Patients who have had a **major surgery** within the last 14 days are not eligible.
Patients with a history of **severe heart problems** that are not stable cannot join the study.
Patients who are currently participating in another clinical trial are not allowed to participate.
Patients with a **serious infection** that is not controlled are excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients with a **blood clotting disorder** that is not managed are not eligible.
Patients who have had a **stroke** in the past 3 months are excluded.
Patients with a **severe liver or kidney disease** cannot participate.

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Verified sites

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Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Verified & featuredResponsive
Warsaw, Poland
Not yet recruiting
Uniwersyteckie Centrum Kliniczne
Verified
Gdansk, Poland

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Investigated drugs

Acetylsalicylic Acid
is a medication commonly known as aspirin. It is used in this clinical trial as part of the standard treatment for patients who have had an acute ischemic stroke. This type of stroke happens when a blood clot blocks a large blood vessel in the brain. Acetylsalicylic acid helps to prevent further blood clots from forming, which can reduce the risk of another stroke. In this study, it is used to see if adding another treatment, called mechanical thrombectomy, can improve patient outcomes when combined with acetylsalicylic acid.
Mechanical Thrombectomy
is a procedure used to remove a blood clot from a large blood vessel in the brain. In this clinical trial, it is being tested to see if it is more effective than standard treatment alone, which includes acetylsalicylic acid, for patients who have had an acute ischemic stroke. The goal of mechanical thrombectomy is to quickly restore blood flow to the brain, which can help reduce the damage caused by the stroke and improve recovery. This study aims to find out if adding this procedure to the standard treatment can lead to better outcomes for patients.

Acetylsalicylic Acid

What is already known about the treatment

Acetylsalicylic Acid – Acetylsalicylic acid, commonly known as aspirin, is administered orally in tablet form. It is widely used in medicine and is well-documented in medical literature. The main therapeutic indication for acetylsalicylic acid in this context is to prevent further clot formation in patients with acute ischemic stroke caused by the blockage of a large blood vessel. At the molecular level, it works by inhibiting an enzyme called cyclooxygenase, which reduces the production of substances that promote inflammation and clotting. Acetylsalicylic acid is classified as a non-steroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.

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 reduction in blood flow. This blockage can result in the death of brain cells due to the lack of oxygen and nutrients. The progression of the disease can lead to symptoms such as sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. As the condition advances, it may cause vision problems, dizziness, loss of balance, or severe headache. The severity and progression of symptoms depend on the location and size of the blockage. Early intervention is crucial to minimize brain damage and improve outcomes.