Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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 occurrence of brain pathology 1) Cortical cerebral microinfarcts 2) Silent lacunar infarction 3)Progression of white matter hyperintensities

2. Secondary endpoint 1) The change of cognitive function evaluated by MMSE-2 2) Individual variable of primary endpoint

3. Safety Endpoint Evaluation 1) Cerebral microbleeds on imaging

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Guro Hospital
• Collaborator: Dt&Sanomedics
• Treatments: Apixaban

Criteria

Inclusion Criteria:

• Patients aged over 19 years old

• Patients with sinus rhythm

• Newly diagnosed of heart failure or aggravated heart failure symptom

1. Dyspnea (≥ NYHA II)

2. 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 Criteria:

• 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