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

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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, 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.

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

    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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

  • Tirofiban

    Tirofiban is administered intravenously and is currently being studied in clinical trials for its effectiveness and safety in treating acute ischemic stroke, particularly in cases involving tandem injury. It is primarily used to prevent blood clots in patients with certain heart conditions. Tirofiban works by inhibiting platelet aggregation, which helps prevent the formation of new clots. It belongs to the pharmacological class of antiplatelet agents.

  • Aspirin

    Aspirin is typically taken orally and is widely used in medicine for its anti-inflammatory and blood-thinning properties. In the context of acute ischemic stroke, it is being compared to tirofiban in clinical trials to evaluate its effectiveness and safety. Aspirin works by inhibiting the enzyme cyclooxygenase, which reduces the production of substances that promote inflammation and clot formation. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.

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 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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508454-26-00Protocol codeATILA-ictus-2021Estimated enrolment240 patientsSponsorFundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).