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NCT05838781: CONSIDERING-AF
DeteCtiON and Stroke PreventIon by MoDEl ScRreenING for Atrial Fibrillation
NA trial testing Risk prediction model in Atrial Fibrillation in 2,112 participants. Completed in 16 May 2024.
16 May 2024
Quick facts
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 2,112 |
| Start date | 4 December 2023 |
| Primary completion | 16 May 2024 |
| Estimated completion | 16 May 2024 |
| Sites | 2 locations across Sweden |
Drugs / interventions tested
- Risk prediction model
- 14-days continuous ECG monitoring
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Atrial Flutter — all drugs for Atrial Flutter →
Sponsor
Bristol-Myers Squibb — full company profile →
Who can join
65 and older, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Atrial fibrillation (AF) is the most common clinical arrhythmia and the prevalence increases with age. AF increases the risk of ischaemic stroke fivefold and accounts for almost one-third of all strokes. As AF is often asymptomatic there are many undetected cases. It is important to find patients with AF and additional risk factors for stroke in order to initiate oral anticoagulation treatment, which can reduce the risk of an ischaemic stroke by 60-70%. Screening is recommended in European guidelines, however the most suitable population and the most suitable device for AF detection remain to be defined. The main objective of this study is to test the hypothesis that AF screening with 14-days continuous ECG monitoring in high-risk individuals identified with a risk prediction model is more effective than routine care in identifying patients with undetected AF. Effectively detecting AF among patients with risk factors for ischaemic stroke has the potential to decrease mortality and morbidity, stroke burden and costs for the society as a whole.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Atrial fibrillation: epidemiology, screening and digital health.
Linz D, Gawalko M, Betz K, Hendriks JM, et al · · 2024 · cited 230× · PMID 38362546 · DOI 10.1016/j.lanepe.2023.100786 -
Randomised, siteless study to compare systematic atrial fibrillation screening using enrichment by a risk prediction model with standard care in a Swedish population aged ≥ 65 years: CONSIDERING-AF study design.
Etminani F, Sandgren E, Holm J, Magnusson P, et al · · 2024 · cited 4× · PMID 38216189 · DOI 10.1136/bmjopen-2023-080639 -
Systematic, randomized atrial fibrillation screening using detailed phenotyping with a risk prediction model combined with patch electrocardiogram in a Swedish population aged 65 years or older: the CONSIDERING-AF trial.
Rakai E, Etminani F, Younan N, Andersson A, et al · · 2025 · cited 1× · PMID 40842182 · DOI 10.1093/europace/euaf190 -
Towards improved detection of subclinical atrial fibrillation - Who could benefit from targeted screening?
Fender AC, Dobrev D. · · 2024 · cited 1× · PMID 39911612 · DOI 10.1016/j.ijcha.2024.101550
Verify or expand the search:
- PubMed search for NCT05838781
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Bristol-Myers Squibb trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05838781 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
- Last refreshed: 22 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05838781.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing