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

January 15, 2021 updated by: Eung Ju Kim, Korea University Guro Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Ansan, Korea, Republic of, 15355
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
        • Contact:
      • Hwaseong-si, Korea, Republic of, 18450
        • Hallym University Dongtan Sacred Heart Hospital
        • Contact:
      • Seongnam-si, Korea, Republic of, 13620
      • Seoul, Korea, Republic of, 03722
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 02841
      • Seoul, Korea, Republic of, 06351
      • Wonju, Korea, Republic of, 26426
        • Wonju Severance Christian Hospital
        • Contact:
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of, 08308
        • Korea University Guro Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New occurrence of brain pathology
Time Frame: 24 weeks
1) Cortical cerebral microinfarcts 2) Silent lacunar infarction 3)Progression of white matter hyperintensities
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of Mini-Mental State Examination-2 (MMSE-2) score
Time Frame: 24 weeks
The change of Mini-Mental State Examination-2 (MMSE-2) score compared to baseline. Higher scores mean a better outcome.
24 weeks
New occurrence of cortical cerebral microinfarcts
Time Frame: 24 weeks
New occurrence of cortical cerebral microinfarcts compared to baseline
24 weeks
New occurrence of silent lacunar infarction
Time Frame: 24 weeks
New occurrence of silent lacunar infarction compared to baseline
24 weeks
Progression of white matter hyperintensities (more than 10% increase)
Time Frame: 24 weeks
Progression of white matter hyperintensities (more than 10% increase) compared to baseline
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Dt&Sanomedics

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 2, 2021

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

January 3, 2021

First Submitted That Met QC Criteria

January 3, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020GR0592

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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