Why the study?
It is unknown whether risk-adapted intensified heart rhythm monitoring with subsequent oral anticoagulation reduces recurrent ischaemic stroke and systemic embolism in ischaemic stroke patients.
Does risk-adapted intensified heart rhythm monitoring with subsequent initiation of oral anticoagulation reduce recurrent ischaemic stroke and systemic embolism in acute ischaemic stroke patients?
RCT (n=5,227)
Open-label with blinded endpoint assessment (PROBE)
1:1
Yes
Does risk-adapted intensified heart rhythm monitoring with subsequent initiation of oral anticoagulation reduce recurrent ischaemic stroke and systemic embolism in acute ischaemic stroke patients?
The Find-AF 2 trial successfully enrolled 5,227 acute ischemic stroke patients to evaluate whether risk-adapted intensified heart rhythm monitoring reduces recurrent stroke and systemic embolism.
: This is a baseline characteristics paper for an ongoing/upcoming RCT.
BACKGROUND: In the Find-AF 2 randomised controlled trial, we investigate whether a risk-adapted intensified heart rhythm monitoring with subsequent initiation of oral anticoagulation in ischaemic stroke patients leads to a reduction of recurrent ischaemic stroke and systemic embolism. The objective of this analysis is to present baseline characteristics of the overall Find-AF 2 study population and stratified by low or high risk for developing AF. METHODS: The Find-AF 2 trial included acute ischaemic stroke patients ≥ 60 years of age within 30 days of ischaemic stroke of any cause. Before randomisation, patients received a 24-h Holter-ECG to exclude those with easily detectable AF and to determine the presence or absence of enhanced supraventricular ectopic activity (ESVEA), used as a marker indicating high or low risk for developing AF. Those without AF were randomly assigned 1:1 to either usual care diagnostics for AF detection (control group) or enhanced, prolonged and intensified ECG monitoring (intervention group). In the intervention group, patients with ESVEA received an implantable cardiac monitor (ICM), whereas those without ESVEA received repeated annual 7-day Holter ECGs. We present baseline characteristics of the overall Find-AF 2 population and stratified by ESVEA. RESULTS: Between July 2020 and July 2024, 5227 patients (mean age 72.3 ± 7.5 years, 40% female, 2618 intervention group, 2609 control group) were randomised from 52 study centres in Germany within a median of 5 (IQR 3-7) days after the index stroke. The most frequent stroke aetiologies were cryptogenic (60%) and small vessel occlusion (19%). 1152 (22%) patients were at high risk for developing AF and 4075 (78%) at low risk. Patients within the high-risk stratum were significantly older (mean age 75.2 versus 71.5 years, p < 0.001), more often had moderate to severe stroke (34% versus 30%, p < 0.001), non-lacunar (70% versus 64%, p < 0.001) and of cryptogenic aetiology (64% vs 58%, p < 0.001). CONCLUSIONS: The Find-AF 2 trial has successfully completed recruitment of a large acute ischaemic stroke population with different stroke subtypes. The follow-up is ongoing and results are expected within two years. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier NCT04371055, registered 24 April 2020.
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Wasser et al. (2025) conducted an RCT in Acute ischaemic stroke (n=5,227). Risk-adapted enhanced, prolonged and intensified ECG monitoring vs. Usual care (at least 24-h Holter ECG) was evaluated on Time to first recurrent ischaemic stroke or systemic embolism.
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