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Heart FailurePhase 2NCT04696120

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

A Phase 2 study testing Apixaban in people with Heart Failure and Sinus Rhythm, run by Korea University Guro Hospital at 10 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Apixaban
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
10 sitesSouth Korea
Study dates
2 Mar 2021to 28 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 1) LVEF ≤ 40%
  • Those with CHA2DS2-VASc ≥ 3
  • Modified Rankin Score ≤ 4

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country.

Eung Ju Kim, MD, PhD contact

82-02-2626-3022

withnoel@empas.com

Jah Yeon Choi, MD, PhD contact

kekeruki@gmail.com

10 sites in 1 country

South Korea10 sites

  • Korea University Ansan Hospital

    Ansan, 15355

    Sung Hwan Kim, MD,PhD., echoshkim@gmail.com

  • Chungnam National University Hospital

    Daejeon, 35015

    Jin Ok Cheong, MD,PhD., jojeong@cnu.ac.kr

  • Hallym University Dongtan Sacred Heart Hospital

    Hwaseong-si, 18450

    Seong Woo Han, MD,PhD., hansw29@hanmail.net

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Dong ju Choi, MD,PhD., djchoi@snubh.org

    Jin Joo Park, MD,PhD., 65755@snubh.org

  • Korea University Guro Hospital

    Seoul, Guro-gu, 08308

  • Korea University Anam Hospital

    Seoul, 02841

    Sung Mi Park, MD,PhD., smparkmd@korea.ac.kr

    Mi-Na Kim, MD,PhD., alsk1229@gmail.com

  • Severance Hospital

    Seoul, 03722

    Seok Min Kang, MD,PhD., SMKANG@yuhs.ac

    Jaewon Oh, MD,PhD., ericjcoh@yuhs.ac

  • Asan Medical Center

    Seoul, 05505

    Min Seok Kim, MD,PhD., guess124@gmail.com

  • Samsung Medical Center

    Seoul, 06351

    Jin Oh Choi, MD,PhD., choijean5@gmail.com

  • Wonju Severance Christian Hospital

    Wŏnju, 26426

    Byeong Soo Yoo, MD,PhD., yubs@yonsei.ac.kr

Other trials in South Korea

About this study

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
Read the 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.

Being tested
Apixaban, Placebo
Keywords
Heart failure, Sinus rhythm, NOAC, Brain
Medical subject headings
Heart Failure, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called apixaban 5mg or 2.5mg bid

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

  • PlaceboDrug

    Also called placebo bid

    All patients who are assigned to placebo group will receive placebo

Study groups in NCT04696120
Study groupRoleWhat they receive
Study group: apixabanExperimentalapixaban 2.5mg or 5mg bid
Receives: Drug: Apixaban
Control group: placeboPlacebo comparatorplacebo bid
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New occurrence of brain pathology

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

    Measured: 24 weeks

Secondary outcomes (4)

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

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

    Measured: 24 weeks

  2. New occurrence of cortical cerebral microinfarcts

    New occurrence of cortical cerebral microinfarcts compared to baseline

    Measured: 24 weeks

  3. New occurrence of silent lacunar infarction

    New occurrence of silent lacunar infarction compared to baseline

    Measured: 24 weeks

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

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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2021
  2. Study start2 Mar 2021 (estimated)
  3. Primary completion30 Aug 2022 (estimated)
  4. Study completion28 Feb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04696120
Sponsor's protocol ID
2020GR0592
Status last verified
Jan 2021
First submitted
3 Jan 2021
Last updated
20 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ponikowski P, Anker SD, AlHabib KF, Cowie MR, Force TL, Hu S, Jaarsma T, Krum H, Rastogi V, Rohde LE, Samal UC, Shimokawa H, Budi Siswanto B, Sliwa K, Filippatos G. Heart failure: preventing disease and death worldwide. ESC Heart Fail. 2014 Sep;1(1):4-25. doi: 10.1002/ehf2.12005.

    PubMed 28834669

  • GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.

    PubMed 27733282

  • Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.

    PubMed 26673558

  • Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.

    PubMed 21262990

  • Nichols GA, Reynolds K, Kimes TM, Rosales AG, Chan WW. Comparison of Risk of Re-hospitalization, All-Cause Mortality, and Medical Care Resource Utilization in Patients With Heart Failure and Preserved Versus Reduced Ejection Fraction. Am J Cardiol. 2015 Oct 1;116(7):1088-92. doi: 10.1016/j.amjcard.2015.07.018. Epub 2015 Jul 15.

    PubMed 26235928

  • Maggioni AP, Dahlstrom U, Filippatos G, Chioncel O, Crespo Leiro M, Drozdz J, Fruhwald F, Gullestad L, Logeart D, Fabbri G, Urso R, Metra M, Parissis J, Persson H, Ponikowski P, Rauchhaus M, Voors AA, Nielsen OW, Zannad F, Tavazzi L; Heart Failure Association of the European Society of Cardiology (HFA). EURObservational Research Programme: regional differences and 1-year follow-up results of the Heart Failure Pilot Survey (ESC-HF Pilot). Eur J Heart Fail. 2013 Jul;15(7):808-17. doi: 10.1093/eurjhf/hft050. Epub 2013 Mar 28.

    PubMed 23537547

  • Ziaeian B, Fonarow GC. Epidemiology and aetiology of heart failure. Nat Rev Cardiol. 2016 Jun;13(6):368-78. doi: 10.1038/nrcardio.2016.25. Epub 2016 Mar 3.

    PubMed 26935038

  • Mamas MA, Sperrin M, Watson MC, Coutts A, Wilde K, Burton C, Kadam UT, Kwok CS, Clark AB, Murchie P, Buchan I, Hannaford PC, Myint PK. Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. Eur J Heart Fail. 2017 Sep;19(9):1095-1104. doi: 10.1002/ejhf.822. Epub 2017 May 3.

    PubMed 28470962

  • Kim W, Kim EJ. Heart Failure as a Risk Factor for Stroke. J Stroke. 2018 Jan;20(1):33-45. doi: 10.5853/jos.2017.02810. Epub 2018 Jan 31.

    PubMed 29402070

  • Divani AA, Vazquez G, Asadollahi M, Qureshi AI, Pullicino P. Nationwide frequency and association of heart failure on stroke outcomes in the United States. J Card Fail. 2009 Feb;15(1):11-6. doi: 10.1016/j.cardfail.2008.09.001. Epub 2008 Dec 25.

    PubMed 19181288

  • Hays AG, Sacco RL, Rundek T, Sciacca RR, Jin Z, Liu R, Homma S, Di Tullio MR. Left ventricular systolic dysfunction and the risk of ischemic stroke in a multiethnic population. Stroke. 2006 Jul;37(7):1715-9. doi: 10.1161/01.STR.0000227121.34717.40. Epub 2006 Jun 1.

    PubMed 16741172

  • Pullicino P, Homma S. Stroke in heart failure: atrial fibrillation revisited? J Stroke Cerebrovasc Dis. 2010 Jan;19(1):1-2. doi: 10.1016/j.jstrokecerebrovasdis.2009.09.002. No abstract available.

    PubMed 20123219

  • Haeusler KG, Laufs U, Endres M. Chronic heart failure and ischemic stroke. Stroke. 2011 Oct;42(10):2977-82. doi: 10.1161/STROKEAHA.111.628479. Epub 2011 Sep 8.

    PubMed 21903953

  • Adelborg K, Szepligeti S, Sundboll J, Horvath-Puho E, Henderson VW, Ording A, Pedersen L, Sorensen HT. Risk of Stroke in Patients With Heart Failure: A Population-Based 30-Year Cohort Study. Stroke. 2017 May;48(5):1161-1168. doi: 10.1161/STROKEAHA.116.016022. Epub 2017 Apr 4.

    PubMed 28377383

  • Kang SH, Kim J, Park JJ, Oh IY, Yoon CH, Kim HJ, Kim K, Choi DJ. Risk of stroke in congestive heart failure with and without atrial fibrillation. Int J Cardiol. 2017 Dec 1;248:182-187. doi: 10.1016/j.ijcard.2017.07.056. Epub 2017 Jul 20.

    PubMed 28826798

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apixaban in people with Heart Failure and Sinus Rhythm, run by Korea University Guro Hospital at 10 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Eung Ju Kim, MD, PhD (82-02-2626-3022, withnoel@empas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New occurrence of brain pathology (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04696120, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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