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 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT02982850
Eligibility Criteria:
Inclusion Criteria:
* Voluntary informed consent
* Diagnosis of AF
* Aortic valvular stenosis, aortic valvular regurgitation, mitral valvular stenosis, or mitral valvular regurgitation of moderate or above severity
* Patients must have one of the following:
* Hypertension requiring medical treatment
* Symptomatic heart failure, New York Heart Association class 2 or higher in the last 6 mon or ejection fraction \<40% documented by echocardiogram
* Age ≥ 65 years
* Diabetes mellitus on treatment
* History of previous stroke, transient ischemic attack, or systemic embolism
* Previous myocardial infarct, peripheral artery disease, or aortic plaque
* Enlarged left atrial size ≥ 40mm documented by echocardiogram
Exclusion Criteria:
* An individual involved in planning or conducting this study
* Unable to understand study conduct or study compliance due to dementia, etc.
* Lack of ability to communicate
* Pregnant woman
* Past cardiac valve replacement
* Stroke resulting in severe disabilities within the past 6 months
* Stroke including silent cerebral infarct within the past 2 weeks
* Chronic renal failure with creatinine clearance \< 30ml/min
* Active hepatitis (≥2 fold increase in liver enzyme levels, known active hepatitis C, active hepatitis B, active hepatitis A)
* High bleeding risk
* Major surgery within the past 1 month
* Planned surgery or procedure within 3 months
* Intracranial, intraocular, intraspinal, or retroperitoneal bleeding history or atraumatic joint bleeding history
* Digestive tract bleeding within the past 1 year
* Symptomatic or endoscopically confirmed gastric or duodenal ulcer within the past 30 days
* Hematologic abnormalities
* Requiring anticoagulant treatment for any reasons other than AF
* Requiring antithrombotics within 48 hours of start of the study
* Uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥100mmHg)
* Recent malignant tumor or 6 months or longer treatment with radiation therapy
* Mean life expectancy ≤3 years
* Contraindication of anticoagulant treatment
* Screening test results as follows
* Platelet count \<80,000 cells/mm3
* Hemoglobin level \<10g/dL
* Previous experience of major bleeding complications
* Participation in another drug study within 3 months prior to enrollment to this study
* Administration of the study drug within 1 month prior to enrollment to this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02982850
Study Brief:
Protocol Section:
NCT02982850