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Ischemic StrokeFind-AF2NCT04371055

Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study

A study testing 7-day Holter ECG and Implantable cardiac monitor in people with Ischemic Stroke and Atrial Fibrillation, run by University of Leipzig at 52 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Patients who have suffered a stroke are having an increased risk of having recurrent stroke in the future. This risk of stroke is increased by atrial fibrillation, which often "comes and goes" (called paroxysmal) and hence escapes routine diagnostics. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Ischemic Stroke, Atrial Fibrillation
What is being tested?
7-day Holter ECG and Implantable cardiac monitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,227 participants
Where
52 sitesGermany
Study dates
7 Jul 2020to 31 Dec 2027
Phase
Interventional
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recent ischemic stroke (sudden focal neurologic deficit lasting > 24h consistent with the territory of a major cerebral artery) and/or a corresponding lesion on brain imaging within the last 30 days
  • Age ≥ 60 years
  • Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symptoms.
  • Written informed consent

Who cannot join

  • Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG
  • Current indication or contraindication for oral anticoagulation at randomisation
  • Intracerebral bleeding in medical history
  • Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.)
  • Implanted pacemaker device or cardioverter/ defibrillator
  • Patient not willing to be treated with oral anticoagulants
Show all 13Show fewer
  • Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
  • History of carotid endarterectomy or percutaneous intervention of cerebral artery within the last 30 days.
  • Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer)
  • patients under legal supervision or guardianship
  • psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties,...) or participate in the required tests
  • participation in other randomised interventional trials
  • suspected lack of compliance

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

Germany52 sites

  • Klinikum Altenburger Land

    Altenburg

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg

  • Universitätsklinikum Augsburg

    Augsburg

  • Rhön Klinikum Campus Bad Neustadt

    Bad Neustadt an der Saale

  • Sozialstiftung Bamberg; Klinikum am Bruderwald

    Bamberg

  • Vivantes Klinikum Neukölln Berlin

    Berlin, State of Berlin

  • BG Klinikum, Unfall-KH Berlin gGmbH

    Berlin

  • Vivantes, Humboldt-Klinikum Berlin

    Berlin

  • Vivantes Klinikum Spandau

    Berlin-Spandau

  • Evangelisches Klinikum Bethel, Klinik für Neurologie

    Bielefeld, 33611

  • Universitätsklinikum Bonn

    Bonn

  • Klinikum Bremen Mitte

    Bremen, Free Hanseatic City of Bremen

  • Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie

    Coburg, 96450

  • Klinikum Darmstadt

    Darmstadt

  • Städtisches Klinikum Dresden, Standort Friedrichstadt

    Dresden

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Universitätsklinikum Erlangen

    Erlangen

  • University of Essen, Clinic for Neurology

    Essen, 45147

  • Klinikum Frankfurt Höchst

    Frankfurt

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Klinikum Fulda

    Fulda

  • Universitätsklinikum Gießen und Marburg GmbH

    Giessen

  • University of Göttingen, Clinic for Neurology

    Göttingen, 37075

  • Bezirkskrankenhaus Günzburg

    Günzburg

  • Krankenhaus Martha-Maria Halle-Dölau

    Halle

  • Albertinenkrankenhaus Hamburg

    Hamburg

  • Asklepios Klinik Altona Hamburg

    Hamburg

  • Asklepios Klinik Wandsbek, Hamburg

    Hamburg

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Klinikum Höxter

    Höxter

  • Klinikum Ibbenbüren

    Ibbenbueren

  • University of Leipzig, Clinic for Neurology

    Leipzig, Saxony, 04103

  • Klinikum St. Georg Leipzig

    Leipzig

  • Städtisches Klinikum Lüneburg gemeinnützige GmbH

    Lüneburg

  • University of Mainz, Clinic for Neurology

    Mainz, 55131

  • Carl-von-Basedow Klinikum Merseburg

    Merseburg

  • Klinikum Minden

    Minden

  • Ökumenisches Hainich Klinikum Mühlhausen

    Mühlhausen

  • ISD München

    München, Bavaria

  • Universitätsklinikum Münster

    Münster

  • Klinikum Nürnberg

    Nuremberg, Bavaria, 90471

  • Klinikum Osnabrück GmbH

    Osnabrück

  • Klinikum Passau

    Passau

  • Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie

    Sande, 26452

  • Kreisklinikum Siegen

    Siegen

  • Kliniken Südostbayern AG, Klinikum Traunstein

    Traunstein

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

  • Helios Dr. Horst Schmidt-Kliniken Wiesbaden

    Wiesbaden

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

About this study

Official title: Intensive Heart Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study

Patients who have suffered a stroke are having an increased risk of having recurrent stroke in the future. This risk of stroke is increased by atrial fibrillation, which often "comes and goes" (called paroxysmal) and hence escapes routine diagnostics. The hypothesis of Find-AF 2 is that enhanced (evaluation in a ECG core lab), prolonged (at least 7 days of rhythm monitoring annually) and intensified (continuous rhythm monitoring in high risk patients) not only finds atrial fibrillation more often, but that changes in therapeutic management (e. g. start of anticoagulation after detection of atrial fibrillation) results in a decrease of cardioembolism (which can be either recurrent stroke or systemic embolism).

To prove this hypothesis, patients will be randomised into two groups: the first group will receive the currently available standard care for patients with stroke. In the second group, cardiac rhythm monitoring adapted to the risk of the occurrence of atrial fibrillation is performed - either with a 7-day long-term ECG (at baseline, after 3 and 12 months and every 12 months thereafter) or with continuous monitoring using an implantable cardiac monitor. If atrial fibrillation is detected, this information will be given to the treating study physician. Any therapeutic decision is at the discretion of the treating physician, but should follow current guidelines.

Read the detailed description

The Find AF 2 study will investigate whether intensified rhythm monitoring in patients with recent ischemic stroke leads to a decrease in recurrent thromboembolism (defined as recurrent ischemic stroke or systemic embolism). This will be achieved by identifying patients with paroxysmal atrial fibrillation and subsequently switching secondary prevention therapy from antiplatelet therapy to oral anticoagulation. The intensity of heart rhythm monitoring will be risk-adjusted: Patients with an estimated low risk of atrial fibrillation receive a 7-day Holter ECG, which is repeated after 3 and 12 months and annually thereafter. Patients with a high risk of atrial fibrillation (defined by increased supraventricular ectopic activity) receive continuous ECG monitoring using an implanted loop recorder. The control arm is treated according to local standards, which includes cardiac rhythm monitoring for at least 24 hours according to current guidelines. Prior to randomization, a 24-hour Holter ECG is performed in both study arms, ensuring minimal ECG monitoring for patients in the control arm and allowing risk stratification in the intervention arm. Additional ECG monitoring using stroke telemetry and/or additional Holter ECGs is possible according to local standards, provided it does not exceed 7 days. Patients in both study arms will be followed up for at least 24 months.

It should be noted that this study only provides diagnostic information, the therapeutic decision is left to the treating physician.

Being tested
7-day Holter ECG, Implantable cardiac monitor, Standard of care
Keywords
Atrial Fibrillation, Ischemic Stroke, ECG Monitoring, Secondary Prevention
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.

  • 7-day Holter ECGOther

    7-day Holter ECG at baseline and after 3 and 12 months and then annually until the end of the study or the first (in patients with low risk of atrial fibrillation)

  • Implantable cardiac monitorOther

    Continuous rhythm monitoring using an implantable cardiac monitor

  • Standard of careOther

    Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)

Study groups in NCT04371055
Study groupRoleWhat they receive
Risk-adapted ECG monitoring for atrial fibrillationExperimentalIntervention Group with high Risk for AF: Continuous Rhythm Monitoring using an implantable cardiac Monitor Intervention group with low risk for AF: 7-day Holter ECG at baseline, after 3 and 12 months and then annually until the end of the study or the first occurrence of atrial Fibrillation
Receives: Other: 7-day Holter ECG; Other: Implantable cardiac monitor
Standard of CareOtherStandard of care rhythm monitoring
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism

    The trial will be event driven. The minimum follow-up in each patient is 24 months, but may be followed for up to 60 months.

    Measured: from the date of randomization until the date of first documented ischemic stroke or date of first systemic embolism, whichever comes first, assessed up to 60 months

  2. Primary safety endpoint: Time until the first haemorrhagic stroke

    Time until the first haemorrhagic stroke

    Measured: from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months

Secondary outcomes (8)

  1. Time until the combination of stroke, myocardial infarction and cardiovascular death

    Time until the combination of stroke, myocardial infarction and cardiovascular death

    Measured: from the date of randomization until the date of first documented stroke, the date of myocardial infarction and the date of cardiovascular death, whichever comes first, assessed up to 60 months

  2. Time until any stroke

    Time until any stroke

    Measured: from the date of randomization until the date of first documented any stroke, assessed up to 60 months

  3. Time until new onset of AF

    Time until new onset of Atrial Fibrillation

    Measured: from the date of randomization until the date of first documented AF, assessed up to 60 months

  4. Time until all cause mortality

    Time until all cause mortality

    Measured: from the date of randomization until the date of all cause mortality assessed up to 60 months

  5. Time until myocardial infarction

    Time until myocardial infarction

    Measured: from the date of randomization until the date of all myocardial infarction, assessed up to 60 months

  6. Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16)

    Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16). The SIS-16 ranges from 16 to 80, with higher scores showing better Quality of life.

    Measured: Mean change from baseline until study end assessed up to 60 months in both study arms

  7. Changes in the EQ-5D five dimensional Quality of Life (QoL)

    Changes in the EQ-5D five dimensional Quality of Life (QoL)

    Measured: Mean change from baseline until study end assessed up to 60 months in both study arms

  8. Changes in the overall QoL visual analog scale

    Changes in the overall QoL visual analog scale

    Measured: Mean change from baseline until study end assessed up to 60 months in both study arms, ranging from 0 to 100, with higher values indicating better quality of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2020
  2. Study start7 Jul 2020
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, parallel, multicenter interventional trial with blinded assessment of the primary endpoint
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04371055
Sponsor's protocol ID
Find-AF 2
Acronym
Find-AF2
Status last verified
Aug 2026
First submitted
24 Apr 2020
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Uhe T, Wasser K, Weber-Kruger M, Schabitz WR, Kohrmann M, Brachmann J, Laufs U, Dichgans M, Gelbrich G, Petroff D, Prettin C, Michalski D, Kraft A, Etgen T, Schellinger PD, Soda H, Bethke F, Ertl M, Kallmunzer B, Grond M, Althaus K, Hamann GF, Mende M, Wagner M, Groschel S, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Intensive heart rhythm monitoring to decrease ischemic stroke and systemic embolism-the Find-AF 2 study-rationale and design. Am Heart J. 2023 Nov;265:66-76. doi: 10.1016/j.ahj.2023.06.016. Epub 2023 Jul 7.

    PubMed 37422010

  • Wasser K, Uhe T, Schabitz WR, Kohrmann M, Dichgans M, Brachmann J, Laufs U, Gelbrich G, Petroff D, Prettin C, Michalski D, Pelz J, Kraft A, Etgen T, Soda H, Bethke F, Schellinger PD, Althaus K, Hamann GF, Grond M, Kallmunzer B, Petersen M, Pallesen LP, Ertl M, Zickler P, Poli S, Haeusler KG, Steiner T, Sparenberg P, Kermer P, Kopczak A, Kellert L, Nuckel M, Liman J, Ringleb PA, Mende M, Wagner M, Bochert D, Schnieder M, Amanzada I, Groschel S, Hahn M, Uphaus T, Groschel K, Wachter R; Find-AF 2 study group. Baseline characteristics of patients with acute ischaemic stroke included in the randomised controlled Find-AF 2 trial. Neurol Res Pract. 2025 Jun 26;7(1):45. doi: 10.1186/s42466-025-00399-8.

    PubMed 40571918

Questions about this trial

What is this clinical trial studying?

A study testing 7-day Holter ECG and Implantable cardiac monitor in people with Ischemic Stroke and Atrial Fibrillation, run by University of Leipzig at 52 sites 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 13 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: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites 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.

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?

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?

Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism (time frame: from the date of randomization until the date of first documented ischemic stroke or date of first systemic embolism, whichever comes first, assessed up to 60 months). The study lists 2 primary outcomes in all. 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 NCT04371055, which also lists 2 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 28 Aug 2026.

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