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

NCT04696120 | Unknown Phase 2

• 1 other identifier: 2020GR0592
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 10

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. 1.New occurrence of brain pathology 1) Cortical cerebral microinfarcts 2) Silent lacunar infarction 3)Progression of white matter hyperintensities
2. 2.Secondary endpoint 1) The change of cognitive function evaluated by MMSE-2 2) Individual variable of primary endpoint
3. 3.Safety Endpoint Evaluation 1) Cerebral microbleeds on imaging

Conditions

Heart Failure; Sinus Rhythm; Cerebrovascular Disease

Keywords

Heart failure; Sinus rhythm; NOAC; Brain

Outcome Measures

Primary Outcomes (1)

• New occurrence of brain pathology

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

  24 weeks

Secondary Outcomes (4)

• The change of Mini-Mental State Examination-2 (MMSE-2) score

  24 weeks

• New occurrence of cortical cerebral microinfarcts

  24 weeks

• New occurrence of silent lacunar infarction

  24 weeks

• Progression of white matter hyperintensities (more than 10% increase)

  24 weeks

Study Arms (2)

Study group: apixaban

EXPERIMENTAL

apixaban 2.5mg or 5mg bid

Drug: Apixaban

Control group: placebo

PLACEBO COMPARATOR

placebo bid

Drug: Placebo

Interventions

Apixaban DRUG

Patients who are randomly assigned to apixaban group will receive apixaban 5mg or 2.5mg bid

Also known as: apixaban 5mg or 2.5mg bid

Study group: apixaban

Placebo DRUG

All patients who are assigned to placebo group will receive placebo

Also known as: placebo bid

Control group: placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \) LVEF ≤ 40%
• Those with CHA2DS2-VASc ≥ 3
• Modified Rankin Score ≤ 4

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Dt&Sanomedics: collaborator

Study Sites (10)

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, 18450, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

Location

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MeSH Terms

Conditions

Heart Failure; Cerebrovascular Disorders

Interventions

apixaban; BID protein, human

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Eung Ju Kim, MD, PhD.

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eung Ju Kim, MD, PhD

CONTACT

82-02-2626-3022; withnoel@empas.com

Jah Yeon Choi, MD, PhD

CONTACT

kekeruki@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 6, 2021
• Study Start: March 2, 2021
• Primary Completion: August 30, 2022
• Study Completion: February 28, 2023
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (10)