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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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Medizinische Hochschule Hannover Hanover Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Klinikum Frankfurt Hoechst GmbH Frankfurt Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Staedtisches Klinikum Lueneburg gGmbH Lueneburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Vivantes Netzwerk fuer Gesundheit GmbH Berlin Germany
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Fundacio Institut De Recerca De L’Hospital De La Santa Creu I Sant Pau Barcelona Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Philipps-Universitaet Marburg Marburg Germany
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Uwjcufyqrg Mqymhlu Cqvagr Hcmkchdvhehgonnaz Hamburg Germany
Uikhzveckdyxemfcszecl Eoaxs Ano Essen Germany
Flklsnitaswmpjboqmhskddocny Nphftpbxrvl Gedn Neumuenster Germany
Udqnlenfpn Hbxjprkw Crdjgce Cologne Germany
Abvzjzgva Uik Amsterdam The Netherlands
Uleewjctfrzyqdxwwpgsy Meggvnps Abn Munster Germany
Gsgqmv Uhbbsbuidt Fbijxswmc Frankfurt Germany
Kmnfesih dpi Uwafkqkbqfoy Mmwikexn Aba Munich Germany
Reoxvpdiegxrpv Al Bad Neustadt A.D.Saale Germany
Hghbquui Uwspnesicloaz Hltxnrkx Tijuf y Pjnhon Ihhmdqpi Cmcygd dzwakudhretmkhipo (mirv Badalona Spain
Hffuwdel Vfya dzzvyyge Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
30.07.2025
Spain Spain
Not yet recruiting
30.07.2025
The Netherlands The Netherlands
Not yet recruiting
30.07.2025

Trial locations

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.

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 ID:
2025-521260-35-00
Protocol code:
EAST-STROKE
NCT ID:
NCT05293080
Trial Phase:
Therapeutic confirmatory (Phase III)

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