Safety and Efficacy of Edoxaban

Safety and Efficacy of Edoxaban in Non-Valvular Atrial Fibrillation Patients at high risk of bleeding in Korea

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003777

Enrollment

550

Registered

2019-04-15

Start date

2019-05-01

Completion date

Unknown

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : edoxaban 30mg, edoxaban 60mg, warfarin 2mg, warfarin 5mg once a day, for 24 months, oral medication ? A comparative clinical trial between the two groups. To compare the difference between edo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Acute ischemic stroke, systemic embolism, major bleeding, death	—

Secondary

Measure	Time frame
Acute ischemic stroke, systemic embolism, death	—

Countries

Korea, Republic of

Contacts

Public ContactInhye PARK

Chonnam National University Hospital

berry101@naver.com+82-62-220-6268

Outcome results