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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02666157
Eligibility Criteria:
Inclusion Criteria: Known AF (paroxysmal or persistent/ permanent) who are suitable and ready for NOAC treatment plus at least one of the following criteria
* Prior ischemic stroke, transient ischemic accident or systemic embolism
* Left ventricular ejection fraction ≤40% (documented by echocardiography or contrast ventriculography)
* Symptomatic congestive heart failure (≥ New York Heart Association Functional Class 2) within 6 months before screening
* Age ≥75 years
* Age ≥65 but \<75 years with diabetes mellitus, hypertension or coronary artery disease
Exclusion Criteria: Subjects are excluded if they have at least one of the following situations before screening:
* Known severe (i.e. hemodynamically significant) mitral stenosis regardless of having received operation
* Time elapsed from the onset of stroke ≤7 days
* Bleeding tendency
* Creatinine clearance rate ≤30 mL/min
* Known active liver disease (persistent elevation of alanine aminotransferase, aspartate transaminase or alkaline phosphatase ≥3 × upper normal limit; or advanced liver cirrhosis ≥Pugh B)
* Pregnancy
* Recent documented active malignancy or radiation therapy (≤6 months) and not expected to survive 3 years
* Unwilling to give informed consent
* Conditions other than AF that required anticoagulation
* Anemia (hemoglobin level \<90 g/L) or thrombocytopenia (platelet count \<100 × 109/L)
* Persistent uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg)
* Active infective endocarditis
* Patients considered unreliable by the investigator or have a life expectancy less than the expected duration of the trial because of concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02666157
Study Brief:
Protocol Section:
NCT02666157