Early treatment of irregular heartbeat (atrial fibrillation) to prevent a recurrent stroke

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Medical Center Hamburg-Eppendorf

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

7 Nov 2025 → ongoing

Decision date (initial)

2025-09-11

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

University Medical Center Hamburg-Eppendorf · German Research Foundation (DFG, for Germany) · European Commission (for Germany, Netherlands and Spain)

External identifiers

EU CT number

2025-521260-35-00

ClinicalTrials.gov

NCT05293080

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Pharmacoeconomic, Safety

To test whether early rhythm-control therapy in addition to usual care reduces the rate of adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation (AF) compared to usual care alone.

Secondary objectives 1

1. To assess the benefit of early rhythm-control therapy in patients with acute ischemic stroke and AF on health-related quality of life and functional outcome and to provide an evaluation of costs of therapy in patients with acute ischemic stroke and AF.

Conditions and MedDRA coding

acute ischemic stroke and atrial fibrillation (AF)

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices

Plan to share IPD

Yes

IPD plan description

All handling of patient data in the clinical trial will comply with the guideline for good clinical practice E6(R2), EMA/CHMP/ICH/135/1995. Anonymous participant-level data will be shared for independent re-use within existing infrastructures supporting open-science, e.g., the Virtual Stroke Trials Archive (VISTA). Possibilities for potential re-use of EAST-STROKE data include but are not limited to individual-patient meta-analyses of early rhythm control. A Data Management Plan (DMP) will be provided to set out details for data sharing. The DMP will identify best practices and specific standards for the data generated and assess their suitability for sharing and re-use in accordance with official guidelines. The DMP will also ensure that data are made available for re-use in a way that protects the privacy of participants. Data protection legislation will be upheld at a national level for all partners as well as at a European level.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Acute ischemic stroke confirmed with standard of care brain imaging or clinical diagnosis
2. Randomisation within 4 weeks of stroke (but as early as possible)
3. AF first detected ≤1 year before randomisation (including paroxysmal AF)
4. At least one ECG within recent 12 months that documents AF
5. Age >45 years
6. Written informed consent

Exclusion criteria 4

1. End-stage cancer or life-expectancy <12 months
2. Prior AF ablation or surgical therapy for AF
3. Patients not suitable for early rhythm control of AF
4. History of AF first diagnosed >12 months prior to randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. A composite of first recurrent ischaemic stroke, haemorrhagic stroke, unclassified stroke, cardiovascular death, or hospitaliza-tion due to worsening of heart failure or due to acute coronary syndrome (ACS), analysed as time to the first occurrence of one of the aforementioned components.

Secondary endpoints 11

1. Each of the components of the primary outcome (each analysed as time to first event): recurrent ischemic stroke, haemor-rhagic stroke, unclassified stroke, cardiovascular death, hospitalization due to worsening of heart failure, and hospitalization due to ACS
2. Recurrent disabling stroke (as time to first event)
3. Recurrent AF (as time to first event)
4. Cardiac rhythm (sinus rhythm vs. AF) at 12 and 24 months
5. Unplanned cardiovascular hospitalization (as time to first hospitalization)
6. Number of cardiovascular hospitalizations
7. Change from baseline in left ventricular function (left ventricular ejection fraction [LVEF]) at 24 months
8. Functional status assessed with the modified Rankin Scale (mRS) at 12 and 24 months
9. Quality of life assessed with the EuroQol five-dimensional questionnaire (EQ-5D) and Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) domains on physical and mental health at 12 and 24 months
10. Cognitive function assessed with the Montreal Cognitive Assessment (MoCA) at 12 and 24 months
11. Cost of therapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Medical Center Hamburg-Eppendorf

Sponsor organisation

University Medical Center Hamburg-Eppendorf

Address

Martinistrasse 52, Eppendorf Eppendorf

City

Hamburg

Postcode

20246

Country

Germany

Scientific contact point

Organisation

University Medical Center Hamburg-Eppendorf

Contact name

Director of the Department of Neurology

Public contact point

Organisation

University Medical Center Hamburg-Eppendorf

Contact name

Director of the Department of Neurology

Third parties 8

Locations

3 EU/EEA countries · 39 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 33 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications