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Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants

This study, called ASPERA, is for people in the UK who have an 'ischemic' stroke (a stroke caused by a blood clot) while they are already taking blood-thinning medication for an irregular heartbeat like atrial fibrillation (AF). Researchers want to better understand these types of strokes and find out which treatments are most effective at preventing future strokes. They will collect information from existing medical records and also follow new patients over a period of up to five years. The aim is to learn more about the characteristics of these strokes and evaluate different ways of preventing them from happening again.

At a glance

Status
Recruiting
Sponsor
University of L'Aquila
Enrolment target
200
Start
12 Feb 2025
Estimated completion
12 Feb 2031

What is this study about?

The ASPERA study is looking into a specific type of stroke called an 'ischemic stroke'. This is the most common kind of stroke, caused by a blood clot blocking blood flow to the brain. What makes this study special is that it focuses on people who have an ischemic stroke even though they are already taking blood-thinning medication (oral anticoagulants) for an irregular heartbeat, such as atrial fibrillation (AF). These medications are usually prescribed to prevent strokes in people with AF, so it's important to understand why some people still have a stroke.

Researchers want to gather information about what happens when someone has a stroke while on these medications. They will look at details like the patient's health history, symptoms, brain scans, and the type of blood thinner they were taking. The study will also compare different strategies used after the stroke to prevent another one, such as whether continuing the same blood thinner or switching to a different approach is more effective. By doing this, the study hopes to improve our understanding and help doctors make better decisions about preventing future strokes.

This study is being carried out in different hospitals and stroke units around the world, with the University of L'Aquila coordinating the effort. It's an 'observational' study, meaning researchers will collect information and observe what happens naturally; they won't be giving out new medications or treatments. They will look at past patient records and also follow new patients in the future. This will give them a broad picture of what's happening in real-world clinical practice.

Key takeaways

  • The ASPERA study investigates strokes in patients already taking blood thinners for irregular heartbeats.
  • It aims to understand why these strokes happen and which treatments best prevent future strokes.
  • Researchers will collect information from existing medical records and follow new patients over time.
  • This is an 'observational' study; no new treatments or medications will be given.
  • Your information could help improve future stroke prevention and care for people like you.
  • Participation involves sharing medical data, with no direct medical risks.

Who may be eligible?

To be part of this study, you need to meet certain requirements. You must be at least 18 years old and have received a clear diagnosis of an ischemic stroke. This diagnosis needs to be supported by a brain scan that shows a clot-related injury consistent with your symptoms.

You also need to have been taking specific oral (by mouth) blood-thinning medication at the time your stroke symptoms started. This means either a 'direct oral anticoagulant' (DOAC), with your last dose taken within 48 hours, or a 'vitamin K antagonist' (VKA, like warfarin) with your blood clotting levels (INR) in a certain range. Crucially, you must also have a previous diagnosis of atrial fibrillation or another similar heart condition that increases your risk of clots.

However, you wouldn't be able to join if your symptoms weren't typical of an acute stroke (for example, if you just fainted or had only dizziness). Also, if you were receiving blood thinners through an injection into a vein or under the skin at the time of your stroke, you wouldn't be eligible.

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.

  1. Are you at least 18 years old?
  2. Did you have an ischemic stroke (stroke caused by a clot)?
  3. Were you taking oral blood thinners at the time of your stroke?
  4. Do you have a diagnosis of atrial fibrillation or a similar heart rhythm problem?
  5. Do your medical records include a brain scan showing the stroke?
Answer every question to see your result.

What does participation involve?

If you are eligible, your participation in this study would mainly involve your medical information being collected. For the 'retrospective' part of the study, researchers will gather information from your existing medical records from up to five years ago. For the 'prospective' part, if you are a new patient joining after your stroke, researchers will collect details about your condition and health journey as it happens. This includes information about your demographic details, clinical symptoms, and brain scan results. You would then be followed up for your health outcomes at 90 days, 1 year, and 5 years after your stroke. This could involve researchers checking your medical records or potentially brief check-ins to monitor your health and any future events like another stroke or bleeding. There are no new medications to take or specific clinic visits required solely for this study.

Potential risks and benefits

This is an observational study, which means researchers are simply collecting existing medical information and following people's health journeys as normal. They are not giving any new treatments or asking you to change your current care. Therefore, there are generally no direct medical risks from participating. The main benefit is that your information will contribute to a better understanding of strokes in people on blood thinners, which could help improve care for future patients. You would also have the right to withdraw your consent for your data to be used at any time, without affecting your medical care.

Locations (47)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Department of Neurology, Sveti Duh University Hospital
    Verified postcode
    Zagreb, Croatia· Recruiting
  • Copenhagen University Hospital, Bispebjerg Hospital
    Verified postcode
    Copenhagen, Denmark· Recruiting
  • Neurology Department, Assiut University Hospitals
    Verified postcode
    Asyut, Egypt· Recruiting
  • Neurology Department, Faculty of Medicine , Ain Shams University
    Verified postcode
    Cairo, Egypt· Recruiting
  • Neurology Unit, Kobry Elkoba Medical Complex
    Verified postcode
    Cairo, Egypt· Recruiting
  • Université Cote d'Azur UR2CA-URRIS, Unité Neurovasculaire, CHU Hôpital Pasteur 2
    Verified postcode
    Nice, France· Recruiting
  • Department of Neurology, Charite, Berlin Germany and Center for Stroke Research (CSB)
    Verified postcode
    Berlin, Germany· Recruiting
  • Department of Neurology, Martin-Luther-University of Halle-Wittenberg
    Verified postcode
    Halle, Germany· Recruiting
  • Neurological Clinic, Marche Polytechnic University
    Verified postcode
    Ancona, Italy· Recruiting
  • SC Neurologia, Stroke Unit, Ospedale di Venere
    Verified postcode
    Bari, Italy· Recruiting
  • IRCCS Istituto delle Scienze Neurologiche
    Verified postcode
    Bologna, Italy· Recruiting
  • SCA Neurologia, USL Umbria 1
    Verified postcode
    Città di Castello, Italy· Recruiting

Common questions

What is an ischemic stroke?

An ischemic stroke happens when a blood clot blocks an artery that supplies blood to the brain, causing damage to brain cells.

What are oral anticoagulants?

These are medications, often called 'blood thinners', that you take by mouth to help stop blood clots from forming or growing larger, especially for conditions like atrial fibrillation.

What is atrial fibrillation (AF)?

AF is a common type of irregular and often fast heartbeat, which can increase the risk of blood clots forming in the heart and potentially causing a stroke.

Will I have to take new medication for this study?

No, this study is 'observational', meaning researchers will only collect information from your existing medical records and follow your current care. No new medications or treatments are involved.

How long will my information be used in this study?

For some patients, researchers will look at records from up to five years in the past. For newer patients joining, your health will be followed for up to five years after your stroke.

How to find out more

Simona Sacco, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Advancing Knowledge in Ischemic Stroke Patients on Oral Anti…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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