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

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04696120
Collaborator
Dt&Sanomedics (Industry)
200
Enrollment
10
Locations
2
Arms
23.9
Anticipated Duration (Months)
20
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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 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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 rhythm with a CHA2DS2-VASc score ≥ 3. All patients would be randomly assigned to either the apixaban group or placebo group. Patients assigned to the apixaban group will receive 5mg bid or 2.5mg bid (patients with at least 2 of the following characteristics: aged≥80-year, bodyweight ≤60kg, serum creatinine 1.5 ml/dL) and patients in the placebo group will receive a placebo of apixaban. Both drugs will be maintained for 6 months. During the study period, all patients will be carefully monitored for thromboembolic events, including stroke. At the beginning of the study and 6 months after randomization, 3T Brain MRI and MMSE-2 test will be performed to identify changes in brain structure and cognitive function.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial
Anticipated Study Start Date :
Mar 2, 2021
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group: apixaban

apixaban 2.5mg or 5mg bid

Drug: Apixaban
Patients who are randomly assigned to apixaban group will receive apixaban 5mg or 2.5mg bid
Other Names:
  • apixaban 5mg or 2.5mg bid

    		•
    Placebo Comparator: Control group: placebo

    placebo bid

    Drug: Placebo
    All patients who are assigned to placebo group will receive placebo
    Other Names:
  • placebo bid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. New occurrence of brain pathology [24 weeks]

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

    Secondary Outcome Measures

    1. The change of Mini-Mental State Examination-2 (MMSE-2) score [24 weeks]

      The change of Mini-Mental State Examination-2 (MMSE-2) score compared to baseline. Higher scores mean a better outcome.

    2. New occurrence of cortical cerebral microinfarcts [24 weeks]

      New occurrence of cortical cerebral microinfarcts compared to baseline

    3. New occurrence of silent lacunar infarction [24 weeks]

      New occurrence of silent lacunar infarction compared to baseline

    4. Progression of white matter hyperintensities (more than 10% increase) [24 weeks]

      Progression of white matter hyperintensities (more than 10% increase) compared to baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Guro Hospital Seoul Guro-gu Korea, Republic of 08308
    2 Korea University Ansan Hospital Ansan Korea, Republic of 15355
    3 Chungnam National University Hospital Daejeon Korea, Republic of 35015
    4 Hallym University Dongtan Sacred Heart Hospital Hwaseong-si Korea, Republic of 18450
    5 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    6 Korea University Anam Hospital Seoul Korea, Republic of 02841
    7 Severance Hospital Seoul Korea, Republic of 03722
    8 Asan Medical Center Seoul Korea, Republic of 05505
    9 Samsung Medical Center Seoul Korea, Republic of 06351
    10 Wonju Severance Christian Hospital Wonju Korea, Republic of 26426

    Sponsors and Collaborators

    • Korea University Guro Hospital
    • Dt&Sanomedics

    Investigators

    • Principal Investigator: Eung Ju Kim, MD, PhD., Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eung Ju Kim, Professor, Korea University Guro Hospital
    ClinicalTrials.gov Identifier:
    NCT04696120
    Other Study ID Numbers:
    • 2020GR0592
    First Posted:
    Jan 6, 2021
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eung Ju Kim, Professor, Korea University Guro Hospital
    Heart failure
    Sinus rhythm
    NOAC
    Brain
    Additional relevant MeSH terms:
    Cerebrovascular Disorders
    Heart Failure
    Apixaban

    Study Results

    No Results Posted as of Jan 20, 2021