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

Verified siteRegistered drugNo placebo
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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

  • Amiodarone

    is a medication that helps control the heart’s rhythm. In this trial it is taken by mouth to try to keep the heartbeat regular in people who have atrial fibrillation after a stroke. By restoring a normal rhythm, doctors hope to lower the chance of another heart problem or stroke.

  • Dronedarone

    is another oral medicine that works to keep the heart beating regularly. In the study it is used early after a stroke in patients with atrial fibrillation to see if keeping the rhythm normal can reduce future heart complications.

  • Propafenone

    is a pill taken by mouth that helps the heart stay in a steady rhythm. The trial tests whether giving this drug soon after a stroke can help prevent further heart issues in people with atrial fibrillation.

  • Flecainide

    is an oral medication that works to maintain a normal heart rhythm. In the study it is tested as an early treatment for patients who have had a stroke and also have atrial fibrillation, with the goal of reducing future cardiovascular problems.

What is already known about the treatment

  • Amiodarone Hydrochloride

    Amiodarone is taken by mouth as a tablet, often given at a dose of 600 mg, and is absorbed through the digestive system. It is an established drug that has been approved for many years and is widely described in medical studies. It helps keep the heart’s rhythm regular by blocking potassium and other ion channels in heart cells, which slows electrical signals that cause irregular beats. It is classified as a class III anti‑arrhythmic medication and is mainly used to treat atrial fibrillation and other serious heart rhythm disorders.

  • Dronedarone Hydrochloride

    Dronedarone is taken orally as a tablet, typically at an 800 mg dose, and is absorbed through the gut. It is an approved medication with extensive clinical data supporting its use for heart rhythm problems. It works by blocking several heart ion channels, especially potassium, which helps to stabilize the heart’s electrical activity. It belongs to the class III anti‑arrhythmic drug group and is used mainly for atrial fibrillation and related rhythm disturbances.

  • Propafenone Hydrochloride

    Propafenone is taken by mouth as a tablet, commonly at a dose of 600 mg, and is absorbed through the gastrointestinal tract. It is an approved medication that has been studied in many clinical trials for rhythm control. It works by blocking sodium channels in heart cells, which slows the spread of electrical impulses and helps maintain a normal rhythm. It is classified as a class Ic anti‑arrhythmic agent and is used primarily for atrial fibrillation and other supraventricular arrhythmias.

  • Flecainide Acetate

    Flecainide is taken orally as a tablet, usually at a dose of 300 mg, and is absorbed through the stomach and intestines. It is an approved drug with a long history of use and is well documented in medical literature for rhythm control. It works by blocking sodium channels in the heart, reducing the speed of electrical signals and preventing abnormal beats. It is a class Ic anti‑arrhythmic medication, indicated mainly for atrial fibrillation and other fast heart rhythm disorders.

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 21 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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