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Study of drug combination therapy for prevention of recurrent stroke in patients with acute ischemic stroke and atrial fibrillation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with acute ischemic stroke and atrial fibrillation, a condition where the heart beats irregularly. The research aims to determine if early treatment to control heart rhythm, along with standard care, can reduce the risk of cardiovascular problems compared to standard care alone.

The study will use several heart rhythm control medications including dronedarone hydrochloride, propafenone hydrochloride, amiodarone hydrochloride, and flecainide acetate. These medications are taken by mouth in tablet form and work to help regulate the heart's rhythm. The maximum daily doses range from 300 to 800 milligrams, depending on the specific medication used.

During the study, patients will be monitored for various heart and blood vessel-related health events, including additional strokes, heart problems requiring hospitalization, and changes in heart function. The study will also track patients' overall well-being, including their ability to perform daily activities, quality of life, and mental function. Participants will be followed for up to 24 months after starting treatment.

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

    Initial assessment

    Your participation begins within 4 weeks after experiencing an acute ischemic stroke (a type of stroke caused by blocked blood flow to the brain).

    Your heart condition called atrial fibrillation (irregular heartbeat) must have been first detected within the past year.

    A heart rhythm test (ECG) from the past 12 months showing atrial fibrillation is required.

  2. Step 2

    Treatment assignment

    You will be assigned to receive either:

    Standard care alone, or

    Standard care plus additional heart rhythm control medication taken by mouth (oral use)

    The heart rhythm medications may include: dronedarone, propafenone, amiodarone, or flecainide

  3. Step 3

    Regular check-ups - 12 months

    Your heart rhythm will be checked

    Your physical abilities will be assessed using a standardized scale

    Your quality of life will be evaluated through questionnaires

    Your thinking and memory abilities will be tested

  4. Step 4

    Regular check-ups - 24 months

    Your heart rhythm will be checked again

    Your heart function will be evaluated

    Your physical abilities will be reassessed

    Your quality of life will be evaluated again

    Your thinking and memory abilities will be retested

  5. Step 5

    Ongoing monitoring

    Throughout the study period, you will be monitored for:

    Any new strokes

    Heart-related hospitalizations

    Heart failure symptoms

    Changes in heart rhythm

    The study will continue until November 2030

Who can join the trial?

7 criteria

  • You must have had a recent acute ischemic stroke (a type of stroke where blood flow to the brain is blocked), confirmed by brain imaging or doctor's diagnosis
  • You must be able to join the study within 4 weeks after having the stroke (preferably as soon as possible)
  • You must have been diagnosed with atrial fibrillation (irregular heartbeat) within the past year. This includes occasional irregular heartbeat episodes
  • You must have at least one ECG (heart rhythm test) from the past 12 months showing atrial fibrillation
  • You must be older than 45 years of age
  • You must be able to provide written informed consent (agreement to participate in the study)
  • Both men and women can participate in this study

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Known pregnancy or breastfeeding
  • Previous history of severe allergic reactions to medications
  • Presence of mechanical heart valves
  • Severe kidney disease (where kidneys are not functioning properly)
  • Active major bleeding
  • History of intracranial hemorrhage (bleeding in the brain)
  • Severe heart failure (when heart cannot pump blood effectively)
  • Life expectancy less than 1 year due to other medical conditions
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • Severe uncontrolled hypertension (high blood pressure)
  • Recent major surgery within the past month
  • Severe liver disease (where liver is not functioning properly)
  • History of drug or alcohol abuse within the past year
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Investigated drugs

Based on the provided trial information, this study appears to focus on rhythm control therapy for atrial fibrillation in stroke patients. However, specific medications are not listed in the provided data. Without explicit medication information in the source data, I cannot provide detailed descriptions of medications used in this trial. The trial appears to compare standard care versus standard care plus rhythm control therapy in patients with atrial fibrillation who have had a stroke, but the specific medications or interventions are not detailed in the source information. If you need information about the medications used in this trial, additional source data would be required.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The trial data only mentions that it studies early rhythm-control therapy in patients with acute ischemic stroke and atrial fibrillation, but doesn't specify any particular medications. To provide accurate medication descriptions, I would need information about specific drugs used in the rhythm-control therapy or other treatments involved in the trial. If you could provide the names of specific medications used in this trial, I would be happy to create descriptions following your requested format: Medication Name – description format.

Investigated diseases

  • Acute Ischemic Stroke

    A condition that occurs when blood flow to an area of the brain is blocked by a clot, causing brain tissue to be deprived of oxygen and nutrients. Brain cells begin to die within minutes of oxygen deprivation, leading to damage in the affected brain area. This damage can cause sudden loss of function in various parts of the body, depending on which brain region is affected.

  • Atrial Fibrillation

    A heart rhythm disorder where the upper chambers of the heart (atria) beat irregularly and often rapidly instead of maintaining a steady rhythm. This irregular beating pattern can cause blood to pool in the heart chambers, which can lead to clot formation. The condition often causes symptoms such as heart palpitations, shortness of breath, and fatigue.

  • Heart Failure

    A chronic condition where the heart muscle cannot pump blood as effectively as it should. The heart continues to work but becomes less efficient at delivering oxygen and nutrients throughout the body. This causes the body to compensate in various ways, often leading to fluid buildup in the lungs and other tissues.

  • Acute Coronary Syndrome

    A group of conditions that occur when blood flow to the heart muscle is suddenly reduced. It includes conditions where the heart muscle experiences reduced blood flow, causing chest pain and discomfort. The reduction in blood flow can affect how well the heart functions.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521260-35-00Protocol codeEAST-STROKEEstimated enrolment1 746 patientsSponsorUniversity Medical Center Hamburg-Eppendorf

sourced from the EU Clinical Trials Register and site verification

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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).