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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT03433235
Eligibility Criteria:
Inclusion Criteria:
1. Acute ischemic strokes (\< 48 h from symptom onset) showing ischemic lesions confirmed by DWI, which are attributable to atrial fibrillation
2. Evidence of persistent or paroxysmal atrial fibrillation (already known or newly detected)
3. Age ≥20 y
4. Patients who provided informed consent
Exclusion Criteria:
1. Transient ischemic attack with no DWI lesions or severe ischemic strokes (NIHSS \>16)
2. Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition or those accompanying with worsening of an existing focal neurological deficit \[NIHSS ≥4\])10 on baseline MRI
3. Mechanical heart valve, rheumatic heart valve disease, or any other conditions requiring strong anticoagulation such as vitamin K antagonist or heparin treatment
4. Concomitant significant atherosclerotic stenosis (\>50%) in the proximal arteries, which are possibly responsible for stroke lesions
5. Recent (\<3 months) history of cerebral bleeding
6. Active internal bleeding or clinically significant bleeding
7. Severe anemia (Hb \<10 g/dL) or bleeding diathesis (platelet count \<100,000/uL or PT-INR \>1.7) (If there is no active bleeding sign, it is permitted to enroll Hb \<9 g/dL , platelet count \<70,000/uL)
8. Uncontrolled hypertension: persistent systolic pressure \>180 mmHg or diastolic pressure \>110 mmHg
9. Active, advanced medical diseases (liver, kidney, pulmonary disease or cancer) with a life expectancy \<6 months
10. Renal impairment (CrCl \<30 mL/min) or undergoing Hemodialysis (or Peritoneal Dialysis)
11. Treatment with a strong inducer of p-glycoprotein (carbamazepine, dexamethasone, doxorubicin, nefazodone, pentobarbital, phenobarbital, prazocin, rifampin, St.John's wort, tenofovir, tipranavir, trazodone, vinblastine)
12. Contraindication to MRI
13. Pregnancy, breast-feeding or having a plan to be pregnant
14. Participation in the other investigational drug trials simultaneously or within 3 months before the first administration of the study medication. Observational studies without an intervention (eg study medication) are allowed.
15. Any clinical conditions (eg abnormal lab tests) unsuitable for undergoing clinical trials at the discretion of the clinical investigators
16. Known hypersensitivity to the study drug (edoxaban), its ingredients, or formulation excipients
17. Patient with liver disease related to coagulation disorder and clinically significant bleeding risk
18. Severe Liver disease
19. Patient who has increase risk of bleeding due to the following disease
* recent gastrointestinal ulcer history
* carcinoma increased risk of bleeding
* recent brain or spinal injury
* recent brain, spinal or optical surgery histroy
* esophageal varix
* arteriovenous malformations
* vascular aneurysms (over 3.5cm)
* intra spinal or cerebral vascular disorder
20. Patient with other anticoagulants
21. intermitant or severe mitral stenosis
22. a pulmonary embolism patient who is hemodynamic unstabled or required thrombolytic therpy or pulmonary emnolectomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03433235
Study Brief:
Protocol Section:
NCT03433235