Safety and Efficacy of Edoxaba
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003777
- Lead Sponsor
- Chonnam National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 550
1. Patients over 18 years of age
2. Patients with atrial fibrillation confirmed by ecg, holter, intracardiac devices within the past year
3. CHA2DS2-VASc score = 2 points High-risk patients with an embolism stroke
4. HAS BLED score = 3 points High-risk patients with bleeding
5. Patients who voluntarily agreed to participate in clinical trials
1. Reversible causes of atrial fibrillation patients
2. Valvular atrial fibrillation patients
3. Chronic renal failure or hemodialysis patients
4. Patients with hypersensitive response to warfarin
5. Patients with hypersensitive response to edoxaban
6. Patients who are taking medications that are prohibited to co-use with warfarin
7. Severe liver disease patients
8. Minors, old man, pregnant woman
9. Patients with increased risk of bleeding
a. Bleeding history from the latest gastric ulcer
b. Recent history of intracranial hemorrhage or intracranial hemorrhage
c. Vascular malformation of spinal cord or cerebrovascular malformation
d. Recent brain damage or spinal cord injury
e. Recent brain surgery, spinal cord surgery, ophthalmic surgery
f. Esophageal varix
g. Arterovenous malformation
h. Vascular aneurysm
i. malignant tumor
10. A combined treatment with other anticoagulants
11. Uncontrolled severe hypertension patients
12. pulmonary thromboembolism patients
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute ischemic stroke, systemic embolism, major bleeding, death
- Secondary Outcome Measures
Name Time Method Acute ischemic stroke, systemic embolism, death