Study on Tirofiban and Aspirin for Patients with Acute Ischemic Stroke Due to Tandem Lesion

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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, leading to potential brain damage. The study compares the effectiveness and safety of two treatments: Tirofiban, a medication given through an intravenous infusion, and Aspirin, which can be administered either as an injection or a tablet. The purpose of the study is to determine which treatment is more effective in preventing reocclusion, which is when a blood vessel that was previously opened becomes blocked again, and to assess the risk of symptomatic bleeding, which is bleeding that causes a noticeable worsening of the patient’s condition.

Participants in the study will receive either Tirofiban or Aspirin as part of their treatment for an acute ischemic stroke that is caused by a tandem lesion, which involves blockages in both the neck and brain arteries. The study will monitor the rate of reocclusion and any instances of symptomatic bleeding. The trial will also evaluate the functional recovery of patients, aiming for a good outcome defined as a low score on a scale that measures disability, 90 days after treatment.

The study is designed to provide valuable information on the best treatment approach for patients with this type of stroke, potentially improving outcomes and reducing complications. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatments being tested.

1 joining the study

Upon joining the study, the patient is confirmed to have an acute ischemic stroke in the anterior territory due to a tandem lesion. The patient must meet specific criteria, including being 18 years or older and having a certain score on a stroke assessment scale.

The patient provides signed informed consent to participate in the trial.

2 initial treatment

The patient receives treatment for the stroke, which may include a procedure called thrombectomy to remove the blockage in the blood vessel.

If necessary, a cervical stent is placed to support the blood vessel.

3 medication administration

The patient is randomly assigned to receive either tirofiban or aspirin as part of the study.

If assigned to tirofiban, the patient receives it as a solution for infusion, which is administered intravenously.

If assigned to aspirin, the patient receives it in tablet form, taken orally.

4 monitoring and follow-up

The patient’s condition is closely monitored to assess the effectiveness and safety of the treatment.

The study aims to determine the rate of reocclusion and any symptomatic bleeding, which is defined as a worsening of the patient’s condition by 4 or more points on a specific stroke scale.

5 evaluation of outcomes

The primary outcomes being evaluated include carotid reocclusion, platelet aggregation phenomena, and symptomatic intracranial hemorrhage.

A secondary outcome is the patient’s functional prognosis, assessed 90 days after treatment, using a scale that measures the degree of disability or dependence in daily activities.

Who Can Join the Study?

Patients must have an acute ischemic stroke in the front part of the brain due to a tandem lesion, which means a blockage in both the neck and brain arteries, and need a procedure called thrombectomy to remove the blockage.
The blockage in the brain must be in specific areas: the carotid “T”, M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery, or the posterior cerebral artery if it has a fetal origin.
The patient must have an ASPECTS score of 6 or higher. This score is a way to measure the extent of a stroke using a CT scan.
Patients must be 18 years of age or older.
Patients must provide a signed informed consent, which means they agree to participate in the study after understanding the details and risks involved.

Who Cannot Join the Study?

Patients who have had a recent major surgery or injury.
Patients with a history of bleeding disorders, which means their blood does not clot properly.
Patients who are currently taking blood-thinning medications, which help prevent blood clots.
Patients with severe liver or kidney disease, which affects how the body processes substances.
Patients who have had a recent heart attack or severe heart problems.
Patients with uncontrolled high blood pressure, meaning their blood pressure is consistently too high.
Patients who are pregnant or breastfeeding.
Patients with a known allergy to the study medications.
Patients who are participating in another clinical trial.
Patients with any other condition that the study doctors believe would make it unsafe for them to participate.

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

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hnnjjelh Umleqlmowhmfo Hbyaqxcz Tdhko y Pfxvdp Iojmdnai Cxamid dcvftigqmlfffivuj (lxnw	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.05.2022

Trial locations

Investigated drugs:

Tirofiban is a medication used in this clinical trial to help prevent blood clots. It works by blocking certain receptors on platelets, which are small blood cells that help with clotting. This action helps to reduce the risk of reocclusion, which is when a blood vessel that has been opened becomes blocked again. Tirofiban is being tested for its effectiveness and safety in patients who have had an ischemic stroke due to a tandem injury.

Aspirin is another medication used in this trial. It is commonly known for its ability to reduce pain and inflammation, but in this context, it is used for its blood-thinning properties. Aspirin helps prevent platelets from clumping together, which can reduce the risk of blood clots forming. In this trial, aspirin is given intravenously to patients to assess its effectiveness and safety compared to tirofiban in preventing complications after an ischemic stroke.

Investigated diseases:

Ischaemic stroke

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 affected brain cells begin to die within minutes, leading to potential loss of function in the areas controlled by the damaged brain region. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. Other signs may involve vision problems, dizziness, loss of balance, or severe headache. The progression of the disease can vary, with some individuals experiencing rapid improvement, while others may have prolonged or worsening symptoms. Early intervention is crucial to minimize brain damage and improve outcomes.

Trial ID:

2023-508454-26-00

Protocol code:

ATILA-ictus-2021

NCT ID:

NCT05225961

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Tirofiban and Aspirin for Patients with Acute Ischemic Stroke Due to Tandem Lesion

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