Acute Ischemic StrokePhase 3EAST-STROKENCT05293080
Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
A Phase 3 study of Acute Ischemic Stroke and Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Atrial Fibrillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,746 participants
- Where
- 1 siteGermany
- Study dates
- 6 Nov 2025to Sep 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) or clinical diagnosis
- Possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable
- AF first detected ≤1 year prior to randomization
- Informed consent
Who cannot join
- End-stage cancer or life-expectancy < 12 months due to other advanced co-morbid illness
- Prior AF ablation or surgical therapy of AF
- Patients not suitable for rhythm control of AF due to cardiac conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
About this study
This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.
Read the detailed description
Atrial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. Usual care comprises oral anticoagulation and rate control. However, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (PROBE) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. Secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. In an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Being tested
- Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version), Usual care for atrial fibrillation
- Keywords
- Acute ischemic stroke, Atrial fibrillation, Rhythm control, Ablation, Antiarrhythmic drugs
- Medical subject headings
- Ischemic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)Other
Therapy for early rhythm control will be either by use of approved antiarrhythmic drugs (e.g. amiodarone, dronedarone, flecainide, propafenone), approved approaches and devices for ablation, or electric cardio version.
Usual care for atrial fibrillationOther
Usual care for atrial fibrillation according to current guidelines. Usual care will mainly comprise rate control by approved drugs. We expect, that usual care will also comprise therapy for rhythm control in a small group of patients.
| Study group | Role | What they receive |
|---|---|---|
| Early rhythm control therapy | Experimental | Patients with acute ischemic stroke and AF will receive either catheter ablation (mainly pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. In case of continuation or recurrence of AF, both modalities may be combined. Receives: Other: Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version) |
| Usual care | Active comparator | Patients with acute ischemic stroke and AF will receive usual care following the current ESC guidelines for AF treatment. Receives: Other: Usual care for atrial fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.
The primary outcome measure is a composite of first recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or due to acute coronary syndrome as recorded by study investigators
Measured: Through study completion, an average of 42 months
Secondary outcomes (12)
Time to first recurrent stroke
Recurrent stroke as recorded by study investigators
Measured: Through study completion, an average of 42 months
Time to cardiovascular death
Measured: Through study completion, an average of 42 months
Time to first hospitalization due to worsening of heart failure
Hospitalization due to worsening of heart failure as recorded by study investigators
Measured: Through study completion, an average of 42 months
Time to hospitalization due to acute coronary syndrome
Hospitalization due to acute coronary syndrome as recorded by study investigators
Measured: Through study completion, an average of 42 months
Time to recurrent AF
Measured: Through study completion, an average of 42 months
Cardiovascular hospitalization
Cardiovascular hospitalization as recorded by study investigators
Measured: Through study completion, an average of 42 months
All-cause hospitalizations
All-cause hospitalizations as recorded by study investigators
Measured: Through study completion, an average of 42 months
Time in sinus rhythm
Measured: Through study completion, an average of 42 months
Functional status assessed by the modified Rankin Scale
Modified Ranking Scale ranging from 0 (no symptoms) to 6 (death) with lower values indicating better status
Measured: at 12 and 24 months
Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D)
The EQ-5D index will be calculated with higher values indicating better health state
Measured: at 12 and 24 months
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
The MoCA ranges for 0 to 30, with higher values indicating better cognitive function
Measured: at 12 and 24 months
Cost of therapy
Measured: Through study completion, an average of 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start6 Nov 2025
- Primary completionJul 2031 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,746 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- University Heart & Vascular Center Hamburg, Department of Cardiology, Department of Neurology, Royal Melbourne Hospital, Melbourne Heart Centre, Royal Melbourne Hospital, Hotchkiss Brain Institute, University of Calgary, UMC Utrecht, Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh, Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre, CTC-NORTH, Stroke Alliance for Europe (SAFE), Kompetenznetz Vorhofflimmern e.V. (AFNET)
- Responsible party
- Sponsor
- Investigators
- Götz Thomalla, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293080
- Sponsor's protocol ID
- EAST-STROKE
- Acronym
- EAST-STROKE
- Status last verified
- May 2026
- First submitted
- 1 Mar 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jensen M, Zapf A, Buchholz A, Mohl A, Andrade JG, Cameron A, Campbell BCV, Fischer U, Hill MD, Kelly P, Kalman JM, Loh P, Molina C, Guasch E, Metzner A, Ng GA, Pagola J, Pontes-Neto OM, Reichlin T, Salman RA, Shoamanesh A, Sposato LA, van der Worp HB, Kirchhof P, Thomalla G. Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE): protocol for an international investigator-initiated, prospective, randomised, open, blinded endpoint assessment (PROBE) interventional multi-centre trial. Eur Stroke J. 2026 May 6;11(5):aakag022. doi: 10.1093/esj/aakag022.
PubMed 42153760
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE
- ClinicalTrials.gov ID
- NCT05293080
- Acronym / sponsor ID
- EAST-STROKE / EAST-STROKE
- Conditions
- Acute Ischemic Stroke, Atrial Fibrillation
- Keywords
- Acute ischemic stroke, Atrial fibrillation, Rhythm control, Ablation, Antiarrhythmic drugs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,746 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- University Heart & Vascular Center Hamburg, Department of Cardiology, Department of Neurology, Royal Melbourne Hospital, Melbourne Heart Centre, Royal Melbourne Hospital, Hotchkiss Brain Institute, University of Calgary, UMC Utrecht, Edinburgh Clinical Trials Unit, Cerebrovascular Research Group, Centre for Clinical Brain Sciences, University of Edinburgh, Department of Cardiovascular Sciences, University of Leicester British Heart Foundation Cardiovascular Research Centre, CTC-NORTH, Stroke Alliance for Europe (SAFE), Kompetenznetz Vorhofflimmern e.V. (AFNET)
- Study start
- 6 Nov 2025 (actual)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.
Detailed description
Atrial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. Usual care comprises oral anticoagulation and rate control. However, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. The Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (PROBE) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. Primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. Secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. In an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early rhythm control therapy | Experimental | Other: Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)Patients with acute ischemic stroke and AF will receive either catheter ablation (mainly pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. In case of continuation or recurrence of AF, both modalities may be combined. |
| Usual care | Active comparator | Other: Usual care for atrial fibrillationPatients with acute ischemic stroke and AF will receive usual care following the current ESC guidelines for AF treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute ischemic stroke in the previous four weeks, diagnosed by imaging (CT or MRI) or clinical diagnosis
- Possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable
- AF first detected ≤1 year prior to randomization
- Informed consent
Key exclusion criteria (3 listed)
- End-stage cancer or life-expectancy < 12 months due to other advanced co-morbid illness
- Prior AF ablation or surgical therapy of AF
- Patients not suitable for rhythm control of AF due to cardiac conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical or interventional therapy for rhythm control in atrial fibrillation (antiarrhythmic drugs, ablation, electric cardio version)Therapy for early rhythm control will be either by use of approved antiarrhythmic drugs (e.g. amiodarone, dronedarone, flecainide, propafenone), approved approaches and devices for ablation, or electric cardio version. | Other | Early rhythm control therapy |
| Usual care for atrial fibrillationUsual care for atrial fibrillation according to current guidelines. Usual care will mainly comprise rate control by approved drugs. We expect, that usual care will also comprise therapy for rhythm control in a small group of patients. | Other | Usual care |
Primary outcome
Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome.
Time frame: Through study completion, an average of 42 months
The primary outcome measure is a composite of first recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or due to acute coronary syndrome as recorded by study investigators
12 secondary outcomes
Time to first recurrent stroke
Time frame: Through study completion, an average of 42 months
Time to cardiovascular death
Time frame: Through study completion, an average of 42 months
Time to first hospitalization due to worsening of heart failure
Time frame: Through study completion, an average of 42 months
Time to hospitalization due to acute coronary syndrome
Time frame: Through study completion, an average of 42 months
Time to recurrent AF
Time frame: Through study completion, an average of 42 months
Cardiovascular hospitalization
Time frame: Through study completion, an average of 42 months
All-cause hospitalizations
Time frame: Through study completion, an average of 42 months
Time in sinus rhythm
Time frame: Through study completion, an average of 42 months
Functional status assessed by the modified Rankin Scale
Time frame: at 12 and 24 months
Quality of life assessed by the EuroQol five-dimensional questionnaire (EQ-5D)
Time frame: at 12 and 24 months
Cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
Time frame: at 12 and 24 months
Cost of therapy
Time frame: Through study completion, an average of 42 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 42153760Jensen M, Zapf A, Buchholz A, Mohl A, Andrade JG, Cameron A, Campbell BCV, Fischer U, Hill MD, Kelly P, Kalman JM, Loh P, Molina C, Guasch E, Metzner A, Ng GA, Pagola J, Pontes-Neto OM, Reichlin T, Salman RA, Shoamanesh A, Sposato LA, van der Worp HB, Kirchhof P, Thomalla G. Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE): protocol for an international investigator-initiated, prospective, randomised, open, blinded endpoint assessment (PROBE) interventional multi-centre trial. Eur Stroke J. 2026 May 6;11(5):aakag022. doi: 10.1093/esj/aakag022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Götz Thomalla, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Acute Ischemic Stroke and Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Märit Jensen, MD (+4940741053770, m.jensen@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recurrent stroke, cardiovascular death, or hospitalization due to worsening of heart failure or due to acute coronary syndrome. (time frame: Through study completion, an average of 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.