Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT01855035
Eligibility Criteria:
Inclusion Criteria:
* Recent cerebral ischemia defined as stroke (sudden focal neurologic deficit lasting \> 24h consistent with the territory of a major cerebral artery and categorised as ischemic) and/or a corresponding lesion on brain imaging.
* Stroke symptoms started ≤ 7 days ago.
* Age ≥ 60 years.
* Modified Rankin scale ≤ 2 (prior to index event).
Exclusion Criteria:
* Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
* Indication for oral anticoagulation at randomisation.
* Absolute contra-indication against oral anticoagulation at randomisation.
* Intracerebral bleeding in medical history.
* Patient scheduled for Holter-ECG or cardiac Event-Recording monitoring ≥ 48 hours.
* Significant carotid artery or vertebral artery stenosis \> 50% (NASCET classification), significant intracranial artery stenosis suspicious of atherosclerotic origin or acute arterial dissection explanatory of stroke symptoms.
* Implanted pacemaker device or cardioverter/defibrillator.
* Life expectancy \< 1 year for reasons other than stroke (e.g. metastatic cancer).
* Concomitant participation in other controlled randomised trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01855035
Study Brief:
Protocol Section:
NCT01855035