Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Randomized Multi-center Clinical Trial to Assess Effectiveness and Safety of Tirofiban Versus Intravenous Aspirin in Patients With Acute Ischemic Stroke Secondary to Tandem Injury, Subject to Recanalization Therapy Through Endovascular Treatment

This research study is for people who have had a severe type of stroke affecting the main artery in their neck (carotid artery) and have received a special treatment to clear the blockage. Doctors want to compare two different medicines, Tirofiban and intravenous aspirin, to see which is more effective and safer. The main goal is to find out which medicine better prevents problems like the artery blocking up again, changes in how blood clots, or serious bleeding in the brain. They will also look at how well people recover overall after 90 days. This is a common type of study (Phase IV) that looks at medicines already in use to learn more about them in specific situations.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla

Enrolment target

240

Start

30 Apr 2024

Acute Ischemic Stroke

What is this study about?

This research study is about helping people who have had a type of stroke called an acute ischemic stroke. This happens when a blood clot blocks blood flow to the brain. Specifically, this study focuses on a severe kind of stroke where the main artery in the neck, called the carotid artery, gets blocked. People in this study would have already received a special treatment to remove the clot and open the artery. The doctors running this study want to find the best way to prevent further problems after this life-saving procedure.

The study aims to compare two different medicines: Tirofiban (also known by brand names like Agnigen or Aggrastat) and intravenous aspirin (given directly into the vein, like Inyesprin). Both of these medicines work to thin the blood and stop clots from forming. The researchers want to see which one works better to keep the artery from blocking up again, prevent excessive blood clotting, or, very importantly, avoid serious bleeding inside the brain following the initial stroke treatment. They are also looking at how well people recover and function in their daily lives after 90 days.

This is a 'Phase IV' study, which means the medicines being tested (Tirofiban and aspirin) are already approved and widely used. This phase of research helps doctors understand more about how these medicines work in very specific situations, like after a severe stroke treated with a clot removal procedure. It's about finding the best way to use existing treatments to achieve the safest and best outcomes for patients.

Key takeaways

This study is for adults who've had a specific type of severe stroke.
It compares two common blood-thinning medicines, Tirofiban and aspirin.
The goal is to prevent further complications after clot-removal treatment.
Researchers are looking for the safest and most effective treatment option.
Participation involves close monitoring and a follow-up for 90 days.
This is a common type of study (Phase IV) for medicines already in use.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 years or older, with no upper age limit. The study is open to both men and women.

The most important factor for joining is having recently experienced a specific type of stroke. This means you would have had an 'acute ischemic stroke' where the main artery in your neck (carotid artery) was blocked, and you would have already undergone a procedure to clear that blockage.

There might be other health conditions or medications that would prevent someone from joining, even if they meet these basic criteria. This is common in research studies to ensure everyone's safety and that the study results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a stroke caused by a blood clot?
Was your stroke linked to a blockage in the main artery in your neck (carotid artery)?
Have you had a treatment to clear that artery blockage?

Answer every question to see your result.

What does participation involve?

If you were to take part in this study, the doctors would randomly assign you to receive one of two medicines: either Tirofiban or intravenous aspirin. This is like flipping a coin, so neither you nor your doctor chooses which medicine you get. You would also receive another anti-clotting medicine called Clopidogrel and standard aspirin tablets, as part of your usual care after a stroke.

Throughout the study, you would have regular check-ups and assessments. These would involve monitoring your health closely, including checking for any complications like re-blocking of the carotid artery, issues with blood clotting, or any signs of bleeding in the brain. The doctors would also assess your recovery and ability to perform daily activities. The main assessments will be focused on the period shortly after your stroke and up to 90 days later.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving very close medical attention from stroke specialists, which can be reassuring. The information gained could also help other stroke patients in the future. However, there are potential risks, primarily related to the medicines being studied, such as bleeding, which is a known side effect of blood-thinning drugs. The research team will monitor you very closely for any side effects or complications. It is important to remember that participation is completely voluntary; you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is an 'acute ischemic stroke'?

It's a type of stroke caused by a blood clot blocking blood flow to your brain. 'Ischemic' means reduced blood supply, and 'acute' means it happened recently and suddenly.

What does 'recanalization therapy' mean?

This is a medical procedure to remove the blood clot and open up the blocked blood vessel in your brain, restoring blood flow.

Why are they comparing Tirofiban and aspirin?

Both are blood-thinning medicines. The study wants to find out which one is safer and more effective at preventing further problems after a severe stroke and clot-removal treatment.

What does 'Phase IV' mean for this study?

It means the medicines being studied are already approved and in use. This phase of research helps doctors learn more about how to use them best in very specific patient situations.

Will I know which medicine I'm getting?

No, you usually won't know because you'll be assigned randomly. This helps make sure the study results are fair and unbiased.