Atrial FibrillationPhase 4EASTNCT01288352
Early Treatment of Atrial Fibrillation for Stroke Prevention Trial
A Phase 4 study of Atrial Fibrillation and Stroke, run by Atrial Fibrillation Network at 11 sites in 11 countries.
Trial summary
EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care. Patients will be randomized to early therapy or usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,789 participants
- Where
- 11 sitesin 11 countries
- Study dates
- 1 Jul 2011to 31 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Recent-onset AF (≤ 1 year prior to enrolment)
- At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 sec.
- One of the following:
- age > 75 years or
- prior stroke or transient ischemic attack
- OR two of the following:
Show all 17Show fewer
- age > 65 years,
- female sex,
- arterial hypertension (chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mmHg),
- diabetes mellitus (treated by drugs or insulin) or impaired glucose tolerance
- severe coronary artery disease (previous myocardial infarction, CABG or PCI)
- stable heart failure (NYHA II or LVEF <50%),
- left ventricular hypertrophy on echocardiography (more than 15 mm wall thickness),
- chronic kidney disease (MDRD stage III or IV),
- peripheral artery disease.
- Provision of signed informed consent.
- Age ≥ 18 years.
Who cannot join
- Any disease that limits life expectancy to less than 1 year.
- Participation in another clinical trial, either within the past two months or ongoing
- Previous participation in the EAST trial.
- Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized.
- Breastfeeding women.
- Drug abuse.
Show all 14Show fewer
- Prior AF ablation or surgical therapy of AF.
- Previous therapy failure on amiodarone, e.g. patients who suffered from symptomatic recurrent AF that required escalation of therapy while on amiodarone.
- Patients not suitable for rhythm control of AF.
- Severe mitral valve stenosis.
- Prosthetic mitral valve.
- Clinically relevant hepatic dysfunction requiring specific therapy.
- Clinically manifest thyroid dysfunction requiring therapy. After successful treatment of thyroid dysfunction, patients may be enrolled when their thyroid function is controlled.
- Severe renal dysfunction (stage V, requiring or almost requiring dialysis).
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST).
EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care.
Patients will be randomized to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. Upon AF recurrence, both modalities will be combined.
Usual care will be conducted following the 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (ECG) monitoring.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- early standardised rhythm control
- Keywords
- early treatment, rhythm control, atrial fibrillation, cardiovascular complications
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early standardised rhythm controlOther
Patients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF.
Early-onset rhythm control therapy can consist of:
- Optimal antiarrhythmic drug therapy
- Catheter ablation with the aim of pulmonary vein isolation (PVI),
- Antiarrhythmic drug therapy and catheter ablation may be combined and supplemented by early cardioversion in patients with persistent AF.
All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual care closely follows the suggestions laid out in the current European Society of Cardiology (ESC) guidelines for AF treatment. In addition to antithrombotic therapy and therapy of underlying heart disease, usual care usually consists of an initial attempt to control symptoms by rate control therapy. Rhythm control interventions are recommended when symptoms can not be controlled by optimal rate control therapy in the usual care group. |
| early standardised rhythm control | Other | Patients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF.
Early-onset rhythm control therapy can consist of:
1. Optimal antiarrhythmic drug therapy (Dronedarone, Amiodarone, Flecainide, Propafenone),
2. Catheter ablation with the aim of pulmonary vein isolation (PVI),
3. Antiarrhythmic drug therapy and catheter ablation may be supplemented by early cardioversion in patients with persistent AF.
All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences. Receives: Other: early standardised rhythm control |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome.
The 1st co-primary outcome parameter is defined as the time to the first occurrence of a composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome. The second co-primary outcome is nights spent in hospital per year.
The 2nd co-primary outcome is nights spent in hospital per year.
Measured: 8 years
Secondary outcomes (1)
Key 2d outcomes: Each of the components of the 1st outcome, time to recurrent AF, cv hospitalizations, all-cause hospitalizations, left ventricular function, QL, cognitive function, cost of therapy.
The 2d outcome parameters are defined as
-all-cause death, AF-related death, time to the 1. occurrence of each of the components of the 1st co-primary outcome, time to recurrent AF (paroxysmal, persistent, long-lasting persistent, permanent) ,AF burden,time to 1. therapy change, time to 1. cv hosp., nr of cv hosp., left ventricular function at 24 months, QoL changes at 24 months and at study termination comp. to baseline, health-related cost calculation and cost of outpatient treatment, change of cognitive function at 24 months compared to BL, cardiac rhythm (sinus rhythm vs. AF), time to: -first symptomatic AF recurrence, -first progression of AF (from paroxysmal to persistent or long-lasting persistent or permanent and each of these components).
The 1st safety outcome:all deaths, the components of the 1st efficacy parameter plus other AEs rel. to the study intervention with special emphasis on proarrhythmia and complications due to interventions.
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2011 (estimated)
- Study start1 Jul 2011
- Primary completion6 Mar 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,789 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrial Fibrillation Network
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Abbott, The German Heart Foundation, European Heart Rhythm Association (EHRA), BMBF (German Ministry for Science), Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor
- Investigators
- Paulus Kirchhof, MD, Principal investigator, University of Birmingham Centre for Cardiovascular Sciences, Department of Cardiology, University Heart and Vascular Center UKE Hamburg, Hamburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01288352
- Sponsor's protocol ID
- EAST- AFNET 4
- Other IDs
- 2010-021258-20
- Acronym
- EAST
- Status last verified
- Jun 2020
- First submitted
- 1 Feb 2011
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will share all data that support published results of the trial. Additional data that have not been published will be withheld until six months after publication of these results. Data will be made available as required for specific, approved analyses. Data will be provided from locked, cleaned and de-identified study database. Requests will be reviewed by AFNET as per the predefined subanalysis plan.
Publications
International Landmark EAST Study Inverstigates Treatment Options for Atrial Fibrillation
Ismaili D, Suling A, Borof K, Goette A, Breithardt G, Camm AJ, Crijns H, Eckardt L, Elvan A, Fabritz L, van Gelder I, Gulizia M, Haegeli L, Heidbuchel H, Kautzner J, Lemoine M, Ng GA, Schnabel RB, Szumowski L, Themistoclakis S, Vardas P, Wegscheider K, Willems S, Zapf A, Metzner A, Rillig A, Kirchhof P. Early rhythm control in patients with atrial fibrillation and cancer: a subgroup analysis of the EAST-AFNET 4 trial. Europace. 2026 Oct 1;28(10):euag269. doi: 10.1093/europace/euag269.
PubMed 42758310Al-Taie C, Obergassel J, Borof K, Ridder J, Rillig A, Metzner A, Goette A, Magnussen C, Sinner MF, Sommerfeld LC, Willems S, Zeller T, Schnabel RB, Schotten U, Zapf A, Kirchhof P, Fabritz L. Interactions of blood biomolecules with early rhythm control in atrial fibrillation patients: exploratory analysis of the EAST-AFNET 4 biomolecule study. Europace. 2026 Jul 3;28(7):euag149. doi: 10.1093/europace/euag149.
PubMed 42334441Schenker N, Borof K, Goette A, Schmidt-Lauber C, Breithardt G, Camm AJ, Crijns H, Eckardt L, Elvan A, Fabritz L, van Gelder I, Gulizia M, Haegeli L, Heidbuchel H, Kautzner J, Lemoine M, Ng GA, Schnabel RB, Suling A, Szumowski L, Themistoclakis S, Vardas P, Wegscheider K, Willems S, Zapf A, Metzner A, Rillig A, Kirchhof P. Effectiveness and Safety of Early Rhythm Control in Patients With Atrial Fibrillation and Chronic Kidney Disease. J Am Coll Cardiol. 2026 Jul 14;88(2):227-241. doi: 10.1016/j.jacc.2026.03.087. Epub 2026 May 13.
PubMed 42126365Koldenhof T, Borof K, Van Gelder IC, Tieleman RG, Lemoine MD, Schnabel RB, Wegscheider K, Kirchhof P, Rienstra M; EAST-AFNET 4 Trial Investigators. Heart rate in early rhythm control therapy in patients with atrial fibrillation. Heart. 2026 Feb 9:heartjnl-2025-326878. doi: 10.1136/heartjnl-2025-326878. Online ahead of print.
PubMed 41663267Metzner A, Willems S, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Fabritz L, Gessler N, Goette A, Reissmann B, Schnabel RB, Schotten U, Zapf A, Rillig A, Kirchhof P. Diabetes and Obesity and Treatment Effect of Early Rhythm Control vs Usual Care in Patients With Atrial Fibrillation: A Secondary Analysis of the EAST-AFNET 4 Randomized Clinical Trial. JAMA Cardiol. 2025 Sep 1;10(9):932-941. doi: 10.1001/jamacardio.2025.2374.
PubMed 40737012Rottner L, Lemoine MD, Eckardt L, Borof K, Camm AJ, Goette A, Breithardt G, Metzner A, Schotten U, Zapf A, Heidbuchel H, Willems S, Crijns H, Schnabel RB, Fabritz L, Magnussen C, Rillig A, Kirchhof P. Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4. Clin Res Cardiol. 2025 May 19. doi: 10.1007/s00392-025-02637-0. Online ahead of print.
PubMed 40387892Kirchhof P, Camm AJ, Crijns HJGM, Piccini JP, Torp-Pedersen C, McKindley DS, Wieloch M, Hohnloser SH. Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria. Europace. 2025 Mar 28;27(4):euaf080. doi: 10.1093/europace/euaf080.
PubMed 40295782Rillig A, Eckardt L, Borof K, Camm AJ, Crijns HJGM, Goette A, Breithardt G, Lemoine MD, Metzner A, Rottner L, Schotten U, Vettorazzi E, Wegscheider K, Zapf A, Heidbuchel H, Willems S, Fabritz L, Schnabel RB, Magnussen C, Kirchhof P. Safety and efficacy of long-term sodium channel blocker therapy for early rhythm control: the EAST-AFNET 4 trial. Europace. 2024 Jun 3;26(6):euae121. doi: 10.1093/europace/euae121.
PubMed 38702961Kany S, Al-Taie C, Roselli C, Pirruccello JP, Borof K, Reinbold C, Suling A, Krause L, Reissmann B, Schnabel RB, Zeller T, Zapf A, Wegscheider K, Fabritz L, Ellinor PT, Kirchhof P. Association of genetic risk and outcomes in patients with atrial fibrillation: interactions with early rhythm control in the EAST-AFNET4 trial. Cardiovasc Res. 2023 Aug 7;119(9):1799-1810. doi: 10.1093/cvr/cvad027.
PubMed 37264683Van Gelder IC, Ekrami NK, Borof K, Fetsch T, Magnussen C, Mulder BA, Schnabel R, Wegscheider K, Rienstra M, Kirchhof P; EAST-AFNET 4 Trial Investigators. Sex Differences in Early Rhythm Control of Atrial Fibrillation in the EAST-AFNET 4 Trial. J Am Coll Cardiol. 2023 Feb 28;81(8):845-847. doi: 10.1016/j.jacc.2022.12.011. No abstract available.
PubMed 36813380Jensen M, Suling A, Metzner A, Schnabel RB, Borof K, Goette A, Haeusler KG, Zapf A, Wegscheider K, Fabritz L, Diener HC, Thomalla G, Kirchhof P. Early rhythm-control therapy for atrial fibrillation in patients with a history of stroke: a subgroup analysis of the EAST-AFNET 4 trial. Lancet Neurol. 2023 Jan;22(1):45-54. doi: 10.1016/S1474-4422(22)00436-7.
PubMed 36517170Eckardt L, Sehner S, Suling A, Borof K, Breithardt G, Crijns H, Goette A, Wegscheider K, Zapf A, Camm J, Metzner A, Kirchhof P. Attaining sinus rhythm mediates improved outcome with early rhythm control therapy of atrial fibrillation: the EAST-AFNET 4 trial. Eur Heart J. 2022 Oct 21;43(40):4127-4144. doi: 10.1093/eurheartj/ehac471.
PubMed 36036648Rillig A, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Goette A, Kuck KH, Metzner A, Vardas P, Vettorazzi E, Wegscheider K, Zapf A, Kirchhof P. Early Rhythm Control in Patients With Atrial Fibrillation and High Comorbidity Burden. Circulation. 2022 Sep 13;146(11):836-847. doi: 10.1161/CIRCULATIONAHA.122.060274. Epub 2022 Aug 15.
PubMed 35968706Goette A, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Kuck KH, Wegscheider K, Kirchhof P; EAST-AFNET 4 Investigators. Presenting Pattern of Atrial Fibrillation and Outcomes of Early Rhythm Control Therapy. J Am Coll Cardiol. 2022 Jul 26;80(4):283-295. doi: 10.1016/j.jacc.2022.04.058.
PubMed 35863844
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Therapy of Atrial Fibrillation for Stroke Prevention Trial (EAST).
- ClinicalTrials.gov ID
- NCT01288352
- Acronym / sponsor ID
- EAST / EAST- AFNET 4
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- early treatment, rhythm control, atrial fibrillation, cardiovascular complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,789 participants (actual)
- Lead sponsor
- Atrial Fibrillation NetworkUniversity, hospital or other
- Collaborators
- Sanofi, Abbott, The German Heart Foundation, European Heart Rhythm Association (EHRA), BMBF (German Ministry for Science), Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 2 Feb 2011 (estimated)
- 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.
EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care.
Patients will be randomized to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. Upon AF recurrence, both modalities will be combined.
Usual care will be conducted following the 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (ECG) monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care closely follows the suggestions laid out in the current European Society of Cardiology (ESC) guidelines for AF treatment. In addition to antithrombotic therapy and therapy of underlying heart disease, usual care usually consists of an initial attempt to control symptoms by rate control therapy. Rhythm control interventions are recommended when symptoms can not be controlled by optimal rate control therapy in the usual care group. |
| early standardised rhythm control | Other | Other: early standardised rhythm controlPatients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF. Early-onset rhythm control therapy can consist of: 1. Optimal antiarrhythmic drug therapy (Dronedarone, Amiodarone, Flecainide, Propafenone), 2. Catheter ablation with the aim of pulmonary vein isolation (PVI), 3. Antiarrhythmic drug therapy and catheter ablation may be supplemented by early cardioversion in patients with persistent AF. All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Recent-onset AF (≤ 1 year prior to enrolment)
- At least one ECG within recent 12 months that documents AF whereas the AF episode must last longer than 30 sec.
- One of the following:
- Provision of signed informed consent.
- Age ≥ 18 years.
Key exclusion criteria (14 listed)
- Any disease that limits life expectancy to less than 1 year.
- Participation in another clinical trial, either within the past two months or ongoing
- Previous participation in the EAST trial.
- Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception [oral contraception or intra-uterine device (IUD)] or sterile women can be randomized.
- Breastfeeding women.
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 |
|---|---|---|
| early standardised rhythm controlPatients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF. Early-onset rhythm control therapy can consist of: 1. Optimal antiarrhythmic drug therapy 2. Catheter ablation with the aim of pulmonary vein isolation (PVI), 3. Antiarrhythmic drug therapy and catheter ablation may be combined and supplemented by early cardioversion in patients with persistent AF. All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences. | Other | early standardised rhythm control |
Primary outcome
A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome.
Time frame: 8 years
The 1st co-primary outcome parameter is defined as the time to the first occurrence of a composite of cardiovascular death, stroke / transient ischemic attack (TIA), and hospitalization due to worsening of heart failure or due to acute coronary syndrome. The second co-primary outcome is nights spent in hospital per year. The 2nd co-primary outcome is nights spent in hospital per year.
1 secondary outcome
Key 2d outcomes: Each of the components of the 1st outcome, time to recurrent AF, cv hospitalizations, all-cause hospitalizations, left ventricular function, QL, cognitive function, cost of therapy.
Time frame: 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Results publicationInternational Landmark EAST Study Inverstigates Treatment Options for Atrial Fibrillation
- Derived from this study: PubMed 42758310Ismaili D, Suling A, Borof K, Goette A, Breithardt G, Camm AJ, Crijns H, Eckardt L, Elvan A, Fabritz L, van Gelder I, Gulizia M, Haegeli L, Heidbuchel H, Kautzner J, Lemoine M, Ng GA, Schnabel RB, Szumowski L, Themistoclakis S, Vardas P, Wegscheider K, Willems S, Zapf A, Metzner A, Rillig A, Kirchhof P. Early rhythm control in patients with atrial fibrillation and cancer: a subgroup analysis of the EAST-AFNET 4 trial. Europace. 2026 Oct 1;28(10):euag269. doi: 10.1093/europace/euag269.
- Derived from this study: PubMed 42334441Al-Taie C, Obergassel J, Borof K, Ridder J, Rillig A, Metzner A, Goette A, Magnussen C, Sinner MF, Sommerfeld LC, Willems S, Zeller T, Schnabel RB, Schotten U, Zapf A, Kirchhof P, Fabritz L. Interactions of blood biomolecules with early rhythm control in atrial fibrillation patients: exploratory analysis of the EAST-AFNET 4 biomolecule study. Europace. 2026 Jul 3;28(7):euag149. doi: 10.1093/europace/euag149.
- Derived from this study: PubMed 42126365Schenker N, Borof K, Goette A, Schmidt-Lauber C, Breithardt G, Camm AJ, Crijns H, Eckardt L, Elvan A, Fabritz L, van Gelder I, Gulizia M, Haegeli L, Heidbuchel H, Kautzner J, Lemoine M, Ng GA, Schnabel RB, Suling A, Szumowski L, Themistoclakis S, Vardas P, Wegscheider K, Willems S, Zapf A, Metzner A, Rillig A, Kirchhof P. Effectiveness and Safety of Early Rhythm Control in Patients With Atrial Fibrillation and Chronic Kidney Disease. J Am Coll Cardiol. 2026 Jul 14;88(2):227-241. doi: 10.1016/j.jacc.2026.03.087. Epub 2026 May 13.
- Derived from this study: PubMed 41663267Koldenhof T, Borof K, Van Gelder IC, Tieleman RG, Lemoine MD, Schnabel RB, Wegscheider K, Kirchhof P, Rienstra M; EAST-AFNET 4 Trial Investigators. Heart rate in early rhythm control therapy in patients with atrial fibrillation. Heart. 2026 Feb 9:heartjnl-2025-326878. doi: 10.1136/heartjnl-2025-326878. Online ahead of print.
- Derived from this study: PubMed 40737012Metzner A, Willems S, Borof K, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Fabritz L, Gessler N, Goette A, Reissmann B, Schnabel RB, Schotten U, Zapf A, Rillig A, Kirchhof P. Diabetes and Obesity and Treatment Effect of Early Rhythm Control vs Usual Care in Patients With Atrial Fibrillation: A Secondary Analysis of the EAST-AFNET 4 Randomized Clinical Trial. JAMA Cardiol. 2025 Sep 1;10(9):932-941. doi: 10.1001/jamacardio.2025.2374.
- Derived from this study: PubMed 40387892Rottner L, Lemoine MD, Eckardt L, Borof K, Camm AJ, Goette A, Breithardt G, Metzner A, Schotten U, Zapf A, Heidbuchel H, Willems S, Crijns H, Schnabel RB, Fabritz L, Magnussen C, Rillig A, Kirchhof P. Safety and efficacy of amiodarone and dronedarone for early rhythm control in EAST-AFNET 4. Clin Res Cardiol. 2025 May 19. doi: 10.1007/s00392-025-02637-0. Online ahead of print.
- Derived from this study: PubMed 40295782Kirchhof P, Camm AJ, Crijns HJGM, Piccini JP, Torp-Pedersen C, McKindley DS, Wieloch M, Hohnloser SH. Dronedarone provides effective early rhythm control: post-hoc analysis of the ATHENA trial using EAST-AFNET 4 criteria. Europace. 2025 Mar 28;27(4):euaf080. doi: 10.1093/europace/euaf080.
- Derived from this study: PubMed 38702961Rillig A, Eckardt L, Borof K, Camm AJ, Crijns HJGM, Goette A, Breithardt G, Lemoine MD, Metzner A, Rottner L, Schotten U, Vettorazzi E, Wegscheider K, Zapf A, Heidbuchel H, Willems S, Fabritz L, Schnabel RB, Magnussen C, Kirchhof P. Safety and efficacy of long-term sodium channel blocker therapy for early rhythm control: the EAST-AFNET 4 trial. Europace. 2024 Jun 3;26(6):euae121. doi: 10.1093/europace/euae121.
- Derived from this study: PubMed 37264683Kany S, Al-Taie C, Roselli C, Pirruccello JP, Borof K, Reinbold C, Suling A, Krause L, Reissmann B, Schnabel RB, Zeller T, Zapf A, Wegscheider K, Fabritz L, Ellinor PT, Kirchhof P. Association of genetic risk and outcomes in patients with atrial fibrillation: interactions with early rhythm control in the EAST-AFNET4 trial. Cardiovasc Res. 2023 Aug 7;119(9):1799-1810. doi: 10.1093/cvr/cvad027.
- Derived from this study: PubMed 36813380Van Gelder IC, Ekrami NK, Borof K, Fetsch T, Magnussen C, Mulder BA, Schnabel R, Wegscheider K, Rienstra M, Kirchhof P; EAST-AFNET 4 Trial Investigators. Sex Differences in Early Rhythm Control of Atrial Fibrillation in the EAST-AFNET 4 Trial. J Am Coll Cardiol. 2023 Feb 28;81(8):845-847. doi: 10.1016/j.jacc.2022.12.011. No abstract available.
- Derived from this study: PubMed 36517170Jensen M, Suling A, Metzner A, Schnabel RB, Borof K, Goette A, Haeusler KG, Zapf A, Wegscheider K, Fabritz L, Diener HC, Thomalla G, Kirchhof P. Early rhythm-control therapy for atrial fibrillation in patients with a history of stroke: a subgroup analysis of the EAST-AFNET 4 trial. Lancet Neurol. 2023 Jan;22(1):45-54. doi: 10.1016/S1474-4422(22)00436-7.
- Individual participant dataSharing planned: Yes. We will share all data that support published results of the trial. Additional data that have not been published will be withheld until six months after publication of these results. Data will be made available as required for specific, approved analyses. Data will be provided from locked, cleaned and de-identified study database. Requests will be reviewed by AFNET as per the predefined subanalysis plan.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Paulus Kirchhof, MD principal investigator
University of Birmingham Centre for Cardiovascular Sciences, Department of Cardiology, University Heart and Vascular Center UKE Hamburg, Hamburg, Germany
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Atrial Fibrillation and Stroke, run by Atrial Fibrillation Network at 11 sites in 11 countries.
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 17 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Belgium, Czechia, Denmark, France, Germany and 6 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite of cardiovascular death, stroke and hospitalization due to worsening of heart failure or due to acute coronary syndrome. (time frame: 8 years). 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 NCT01288352, which also lists 19 linked publications.
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 23 Jul 2020.