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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT04218266
Eligibility Criteria:
Inclusion Criteria:
* Participant must be 45 years of age or older at the time of signing the informed consent.
* Participant with AF documented by ECG evidence with
* CHA2DS2-VASc score ≥ 2 if male or CHA2DS2-VASc score ≥ 3 if female
* Indication for treatment with an oral anticoagulant in
* any participant currently not treated with an oral anticoagulant (e.g. treatment naïve) or alternatively,
* participant on a NOAC in case of at least one bleeding risk feature (history of a prior bleed within the last 12 months requiring medical attention and / or moderate renal dysfunction with eGFR 30-50 ml/min and / or current clinically indicated antiplatelet therapy with Acetylsalicylic acid(ASA) ≤ 100 mg)
* Written informed consent
Exclusion Criteria:
* Mechanical heart valve prosthesis
* Any degree of rheumatic mitral stenosis or moderate-to-severe, non-rheumatic mitral stenosis
* Atrial fibrillation due to a reversible cause, participants in sinus rhythm after successful ablation, or plan for cardioversion or ablation during study conduct
* Requirement for chronic anticoagulation (for a different indication than AF) or antiplatelet therapy (up to 100 mg ASA is allowed). Anticipated need for chronic therapy with Nonsteroidal anti-inflammatory drugs (NSAIDs)
* Treated with a Vitamin K antagonist in the 30 days prior to screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT04218266
Study Brief:
Protocol Section:
NCT04218266