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:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT04696120
Eligibility Criteria:
Inclusion Criteria:
* Patients aged over 19 years old
* Patients with sinus rhythm
* Newly diagnosed of heart failure or aggravated heart failure symptom
1. Dyspnea (≥ NYHA II)
2. plasma BNP ≥ 200 pg/ml or NT-proBNP ≥ 800 pg/ml
* LV systolic dysfunction on echocardiography within 3 month of enrollment
1\) LVEF ≤ 40%
* Those with CHA2DS2-VASc ≥ 3
* Modified Rankin Score ≤ 4
Exclusion Criteria:
* Patients already subscribed warfarin or antiplatelet therapy or have clear indication for warfarin or antiplatelet therapy
* At high risk for bleeding
* Patients with atrial fibrillation
* Estimated glomerular filtration rate (CKD-EPI formula) \< 15 ml/min/1.73 m2)
* Recent stroke or brain hemorrhage (within 3 months)
* Patients who was diagnosed of myocardial infarction or who has plan to PCI/CABG at enrollment
* End stage heart failure with life expectancy ≤ 6 months
* Patients with bed ridden status (Modified Rankin Score ≥ 5)
* Patients with liver dysfunction (AST, ALT \> 2 times of upper normal limits or total bilirubin \> 1.5 of upper normal limits)
* At of pregnancy or breastfeeding
* Patients who disagree with the use of medically acceptable contraception during the clinical trial period
* Patients with contraindication of apixaban
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04696120
Study Brief:
Protocol Section:
NCT04696120