Status:
UNKNOWN
Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial
Lead Sponsor:
Korea University Guro Hospital
Collaborating Sponsors:
Dt&Sanomedics
Conditions:
Heart Failure
Sinus Rhythm
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
objectives: The primary aim of APIXBRAIN-HF Trial is to explore the effects of apixaban on brain protection in patients with sinus rhythm and heart failure Primary / Secondary Endpoint 1. New occurr...
Detailed Description
This study is a double-blind, parallel-group, and randomization study. The investigators will enroll the patients with heart failure who demonstrated LV systolic dysfunction (LVEF ≤ 40%) and sinus rhy...
Eligibility Criteria
Inclusion
- Patients aged over 19 years old
- Patients with sinus rhythm
- Newly diagnosed of heart failure or aggravated heart failure symptom
- Dyspnea (≥ NYHA II)
- plasma BNP ≥ 200 pg/ml or NT-proBNP ≥ 800 pg/ml
- LV systolic dysfunction on echocardiography within 3 month of enrollment
- 1\) LVEF ≤ 40%
- Those with CHA2DS2-VASc ≥ 3
- Modified Rankin Score ≤ 4
Exclusion
- Patients already subscribed warfarin or antiplatelet therapy or have clear indication for warfarin or antiplatelet therapy
- At high risk for bleeding
- Patients with atrial fibrillation
- Estimated glomerular filtration rate (CKD-EPI formula) \< 15 ml/min/1.73 m2)
- Recent stroke or brain hemorrhage (within 3 months)
- Patients who was diagnosed of myocardial infarction or who has plan to PCI/CABG at enrollment
- End stage heart failure with life expectancy ≤ 6 months
- Patients with bed ridden status (Modified Rankin Score ≥ 5)
- Patients with liver dysfunction (AST, ALT \> 2 times of upper normal limits or total bilirubin \> 1.5 of upper normal limits)
- At of pregnancy or breastfeeding
- Patients who disagree with the use of medically acceptable contraception during the clinical trial period
- Patients with contraindication of apixaban
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04696120
Start Date
March 2 2021
End Date
February 28 2023
Last Update
January 20 2021
Active Locations (10)
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1
Korea University Guro Hospital
Seoul, Guro-gu, South Korea, 08308
2
Korea University Ansan Hospital
Ansan, South Korea, 15355
3
Chungnam National University Hospital
Daejeon, South Korea, 35015
4
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, South Korea, 18450