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

Condition(s) studied

Investigational drug(s) / intervention(s)

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)

Implantable cardiac monitor: Continuous rhythm monitoring using an implantable cardiac monitor

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

Study 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. 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.

Eligibility

Primary outcome measure(s)

• Primary efficacy endpoint: Time until recurrent ischemic stroke or systemic embolism — 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.
• Primary safety endpoint: Time until the first haemorrhagic stroke — from the date of randomization until the date of first documented haemorrhagic stroke, assessed up to 60 months
  Time until the first haemorrhagic stroke

Trial sites (52)

+ 12 more sites — see the full list on the official registry below.

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