Not recruiting

Study on the Effectiveness of Alteplase as an Add-On to Mechanical Thrombectomy for Patients with Acute Ischemic Stroke

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 patients who have experienced an acute ischemic stroke, a condition where blood flow to a part of the brain is blocked, often by a blood clot. The study is investigating the use of a medication called Alteplase, also known by its code name rt-PA, as an additional treatment to a procedure called mechanical thrombectomy. Mechanical thrombectomy is a method used to physically remove the clot from the blood vessel in the brain. The goal of the study is to determine if adding Alteplase can improve the outcomes for patients who have already undergone this procedure and have achieved a significant reopening of the blocked blood vessel.

Participants in the study will receive either the medication or a placebo after their mechanical thrombectomy procedure. The study will monitor the patients over a period of time to assess the effects of the treatment. This includes checking the blood flow in the brain using imaging techniques like CT Perfusion, which is a type of scan that shows how blood is moving through the brain. The study will also evaluate the patients' recovery and ability to perform daily activities after 90 days.

The purpose of this research is to explore whether the combination of mechanical thrombectomy and Alteplase can lead to better recovery outcomes for patients who have suffered an acute ischemic stroke. By understanding the potential benefits of this treatment approach, the study aims to improve the care and recovery of stroke patients in the future.

The research process

The trial runs in 4 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, eligibility is confirmed based on specific criteria. These include having a large vessel blockage in the brain's anterior circulation, being treated with a procedure called mechanical thrombectomy, and achieving a certain score on an angiographic test.
The patient must be at least 18 years old, have no significant disability before the stroke, and provide informed consent.
Step 2
Treatment administration
The treatment involves the use of a medication called alteplase, which is administered directly into the arteries. This medication is provided as a solution for injection or infusion.
The administration of alteplase must occur within 24 hours from the onset of stroke symptoms.
Step 3
Monitoring and evaluation
After the treatment, the patient undergoes a CT Perfusion scan approximately 36 hours later to assess blood flow in the brain.
The primary goal is to determine the proportion of patients with abnormal blood flow in small blood vessels.
Step 4
Follow-up assessment
A follow-up assessment is conducted 90 days after the treatment to evaluate the patient's recovery.
The secondary goal is to measure the proportion of patients who achieve a low score on a disability scale, indicating minimal or no disability.

Who can join the trial?

6 criteria

Patients must have a blockage in a large blood vessel in the front part of the brain, treated with a procedure called mechanical thrombectomy (MT), resulting in a good blood flow score (mTICI score 2b/3).
The time from when symptoms started to when a medication called rt-PA is given should be less than 24 hours. This time is counted from when the patient was last known to be well.
Patients should not have significant disability before the stroke, as measured by a scale called the modified Rankin scale (mRS). A score of 0-1 is acceptable, or a higher score if it is not due to a neurological issue (like amputation or blindness).
Patients must be 18 years old or older.
If symptoms have lasted less than 4.5 hours, a brain scan called a non-contrast CT (NCCT) should show a score of 6 or more on the ASPECTS scale. If symptoms have lasted more than 4.5 hours, other scans like CT-perfusion or MRI-perfusion may be needed, especially if more than 9 hours have passed or if the patient is very ill (with a high NIHSS score). If these scans are not available, an NCCT can still be used if the ASPECTS score is 6 or more.
Consent must be obtained from the patient or a suitable representative.

Who cannot join the trial?

4 criteria

Patients who have had a recent **stroke** caused by a **blood clot** in the brain.
Patients who have not achieved **complete or near-complete blood flow restoration** in a major brain artery after a procedure to remove the clot.
Patients who are not within the specified **age range** for the study.
Patients who belong to a **vulnerable population**, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain
Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Hospital Universitari De Girona Doctor Josep Trueta
Verified
Girona, Spain

Trial locations

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Investigated drugs

rt-PA is a medication used in this trial to help dissolve blood clots in patients who have had an acute ischemic stroke. It is being tested to see if it is effective when used in addition to a procedure called mechanical thrombectomy, which is a treatment that physically removes the clot from the blood vessel in the brain. The goal is to determine if adding rt-PA can improve the outcomes for patients who have already had successful or nearly successful removal of the clot through the mechanical procedure.

Alteplase

What is already known about the treatment

rt-PA – This medication is administered intravenously and is used as an add-on treatment to mechanical thrombectomy in patients experiencing an acute ischemic stroke. It is currently being studied in clinical trials to assess its effectiveness in improving outcomes when combined with mechanical procedures. The main therapeutic indication for rt-PA is to aid in the removal of blood clots in the brain, which can help restore blood flow and reduce the severity of a stroke. At the molecular level, rt-PA works by converting plasminogen to plasmin, an enzyme that breaks down fibrin clots. It is classified as a thrombolytic agent, commonly known as a clot-busting drug.

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 blockage can cause brain cells to begin dying within minutes, leading to potential loss of brain function. Symptoms often include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The progression of the disease can lead to significant neurological impairment if not addressed promptly. The severity and specific symptoms depend on the location and extent of the blockage. Early intervention is crucial to minimize brain damage and improve outcomes.