Intensive Rhythm Monitoring to Decrease Ischemic Stroke and Systemic Embolism - the Find-AF 2 Study (Find-AF2)

August 25, 2026 updated by: Rolf Wachter, University of Leipzig

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5227

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Altenburg, Germany
        • Klinikum Altenburger Land
      • Aschaffenburg, Germany
        • Klinikum Aschaffenburg-Alzenau
      • Augsburg, Germany
        • Universitätsklinikum Augsburg
      • Bad Neustadt an der Saale, Germany
        • Rhön Klinikum Campus Bad Neustadt
      • Bamberg, Germany
        • Sozialstiftung Bamberg; Klinikum am Bruderwald
      • Berlin, Germany
        • BG Klinikum, Unfall-KH Berlin gGmbH
      • Berlin, Germany
        • Vivantes, Humboldt-Klinikum Berlin
      • Berlin-Spandau, Germany
        • Vivantes Klinikum Spandau
      • Bielefeld, Germany, 33611
        • Evangelisches Klinikum Bethel, Klinik für Neurologie
      • Bonn, Germany
        • Universitätsklinikum Bonn
      • Coburg, Germany, 96450
        • Klinikum Coburg, Medizinische Klinik für Innere Medizin und Kardiologie
      • Darmstadt, Germany
        • Klinikum Darmstadt
      • Dresden, Germany
        • Universitätsklinikum Carl Gustav Carus
      • Dresden, Germany
        • Städtisches Klinikum Dresden, Standort Friedrichstadt
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany, 45147
        • University of Essen, Clinic for Neurology
      • Frankfurt, Germany
        • Klinikum Frankfurt Höchst
      • Frankfurt, Germany
        • Universitätsklinikum Frankfurt
      • Fulda, Germany
        • Klinikum Fulda
      • Giessen, Germany
        • Universitätsklinikum Gießen und Marburg GmbH
      • Göttingen, Germany, 37075
        • University of Göttingen, Clinic for Neurology
      • Günzburg, Germany
        • Bezirkskrankenhaus Günzburg
      • Halle, Germany
        • Krankenhaus Martha-Maria Halle-Dölau
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf
      • Hamburg, Germany
        • Albertinenkrankenhaus Hamburg
      • Hamburg, Germany
        • Asklepios Klinik Altona Hamburg
      • Hamburg, Germany
        • Asklepios Klinik Wandsbek, Hamburg
      • Hanover, Germany
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany
        • Universitatsklinikum Heidelberg
      • Höxter, Germany
        • Klinikum Höxter
      • Ibbenbueren, Germany
        • Klinikum Ibbenbüren
      • Leipzig, Germany
        • Klinikum St. Georg Leipzig
      • Lüneburg, Germany
        • Städtisches Klinikum Lüneburg gemeinnützige GmbH
      • Mainz, Germany, 55131
        • University of Mainz, Clinic for Neurology
      • Merseburg, Germany
        • Carl-von-Basedow Klinikum Merseburg
      • Minden, Germany
        • Klinikum Minden
      • Mühlhausen, Germany
        • Ökumenisches Hainich Klinikum Mühlhausen
      • Münster, Germany
        • Universitatsklinikum Munster
      • Osnabrück, Germany
        • Klinikum Osnabrück GmbH
      • Passau, Germany
        • Klinikum Passau
      • Sande, Germany, 26452
        • Nordwest-Krankenhaus Sanderbusch, Klinik für Neurologie
      • Siegen, Germany
        • Kreisklinikum Siegen
      • Traunstein, Germany
        • Kliniken Südostbayern AG, Klinikum Traunstein
      • Tübingen, Germany
        • Universitätsklinikum Tübingen
      • Ulm, Germany
        • Universitätsklinikum Ulm
      • Wiesbaden, Germany
        • Helios Dr. Horst Schmidt-Kliniken Wiesbaden
      • Würzburg, Germany
        • Universitätsklinikum Würzburg
    • Bavaria
      • München, Bavaria, Germany
        • ISD München
      • Nuremberg, Bavaria, Germany, 90471
        • Klinikum Nürnberg
    • Free Hanseatic City of Bremen
      • Bremen, Free Hanseatic City of Bremen, Germany
        • Klinikum Bremen Mitte
    • Saxony
      • Leipzig, Saxony, Germany, 04103
        • University of Leipzig, Clinic for Neurology
    • State of Berlin
      • Berlin, State of Berlin, Germany
        • Vivantes Klinikum Neukölln Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Age ≥ 60 years
  3. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symptoms.
  4. Written informed consent

Exclusion Criteria:

  1. Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG
  2. Current indication or contraindication for oral anticoagulation at randomisation
  3. Intracerebral bleeding in medical history
  4. Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.)
  5. Implanted pacemaker device or cardioverter/ defibrillator
  6. Patient not willing to be treated with oral anticoagulants
  7. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
  8. History of carotid endarterectomy or percutaneous intervention of cerebral artery within the last 30 days.
  9. Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer)
  10. patients under legal supervision or guardianship
  11. 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
  12. participation in other randomised interventional trials
  13. suspected lack of compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Risk-adapted ECG monitoring for atrial fibrillation

Intervention 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
Other: 7-day Holter ECG
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)
Other: Implantable cardiac monitor
Continuous rhythm monitoring using an implantable cardiac monitor
Other: Standard of Care
Standard of care rhythm monitoring
Other: Standard of care
Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 trial will be event driven. The minimum follow-up in each patient is 24 months, but may be followed for up to 60 months.
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
Primary safety endpoint: Time until the first haemorrhagic stroke
Time Frame: from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months
Time until the first haemorrhagic stroke
from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time until the combination of stroke, myocardial infarction and cardiovascular death
Time Frame: 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
Time until the combination of stroke, myocardial infarction and cardiovascular death
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
Time until any stroke
Time Frame: from the date of randomization until the date of first documented any stroke, assessed up to 60 months
Time until any stroke
from the date of randomization until the date of first documented any stroke, assessed up to 60 months
Time until new onset of AF
Time Frame: from the date of randomization until the date of first documented AF, assessed up to 60 months
Time until new onset of Atrial Fibrillation
from the date of randomization until the date of first documented AF, assessed up to 60 months
Time until all cause mortality
Time Frame: from the date of randomization until the date of all cause mortality assessed up to 60 months
Time until all cause mortality
from the date of randomization until the date of all cause mortality assessed up to 60 months
Time until myocardial infarction
Time Frame: from the date of randomization until the date of all myocardial infarction, assessed up to 60 months
Time until myocardial infarction
from the date of randomization until the date of all myocardial infarction, assessed up to 60 months
Changes in quality of life (QoL), measured by the stroke impact scale (SIS-16)
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms
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.
Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the EQ-5D five dimensional Quality of Life (QoL)
Time Frame: Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the EQ-5D five dimensional Quality of Life (QoL)
Mean change from baseline until study end assessed up to 60 months in both study arms
Changes in the overall QoL visual analog scale
Time Frame: 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
Changes in the overall QoL visual analog scale
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Leipzig

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johannes Gutenberg University Mainz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rolf Wachter, Prof. Dr., University of Leipzig, Clinic and Policlinis for Cardiology
  • Principal Investigator: Klaus Gröschel, Prof. Dr., University of Mainz, Clinic and Policlinis for Neurology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Find-AF 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

after publication of the major results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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