Effects of APIXaban on BRAIN Protection in Patients With Sinus Rhythm and Heart Failure: APIXBRAIN-HF Trial
NCT ID: NCT04696120
Last Updated: 2021-01-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
200 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-03-02
Study Completion Date
2023-02-28
Brief Summary
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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
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
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Detailed Description
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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.
Conditions
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Heart Failure
Sinus Rhythm
Cerebrovascular Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Study group: apixaban
apixaban 2.5mg or 5mg bid
Group Type
EXPERIMENTAL
Apixaban
Intervention Type
DRUG
Patients who are randomly assigned to apixaban group will receive apixaban 5mg or 2.5mg bid
Control group: placebo
placebo bid
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
All patients who are assigned to placebo group will receive placebo
Interventions
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Apixaban
Patients who are randomly assigned to apixaban group will receive apixaban 5mg or 2.5mg bid
Intervention Type
DRUG
Placebo
All patients who are assigned to placebo group will receive placebo
Intervention Type
DRUG
Other Intervention Names
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apixaban 5mg or 2.5mg bid
placebo bid
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dt&Sanomedics
INDUSTRY
Sponsor Role
collaborator
Korea University Guro Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Eung Ju Kim
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Eung Ju Kim, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Korea University Guro Hospital
Seoul, Guro-gu, South Korea
Site Status
Korea University Ansan Hospital
Ansan, , South Korea
Site Status
Chungnam National University Hospital
Daejeon, , South Korea
Site Status
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, , South Korea
Site Status
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Site Status
Korea University Anam Hospital
Seoul, , South Korea
Site Status
Severance Hospital
Seoul, , South Korea
Site Status
Asan Medical Center
Seoul, , South Korea
Site Status
Samsung Medical Center
Seoul, , South Korea
Site Status
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Site Status
Countries
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South Korea
Central Contacts
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Facility Contacts
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References
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BACKGROUND
Kim BJ, Kwon SU, Park JM, Hwang YH, Heo SH, Rha JH, Lee J, Park MS, Kim JT, Song HJ, Park JH, Yu S, Lee SJ, Park TH, Cha JK, Kwon HM, Kim EG, Lee SH, Lee JS, Lee J, Kang DW. Blood Pressure Variability Is Associated With White Matter Lesion Growth in Intracranial Atherosclerosis. Am J Hypertens. 2019 Aug 14;32(9):918-924. doi: 10.1093/ajh/hpz068.
Reference Type
BACKGROUND
Other Identifiers
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2020GR0592
Identifier Type: -
Identifier Source: org_study_id
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Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation
NCT06433479
COMPLETED
NA
Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients
NCT02200822
COMPLETED
PHASE4
LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.
NCT07202897
NOT_YET_RECRUITING
PHASE3
Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban)
NCT03455439
COMPLETED
A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction
NCT05139615
TERMINATED
PHASE2
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
NCT01067833
TERMINATED
PHASE2
Dapagliflozin and Effect on Cardiovascular Events in Acute Heart Failure -Thrombolysis in Myocardial Infarction 68 (DAPA ACT HF-TIMI 68)
NCT04363697
COMPLETED
PHASE4
Dapagliflozin on Outcomes of Rhythm Control Strategy (Pharmacological ± Interventional) in Patient with Atrial Fibrillation
NCT06759909
NOT_YET_RECRUITING
PHASE1
St. Vincent's Screening To Prevent Heart Failure Study
NCT00921960
COMPLETED
NA
Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure
NCT05598333
ACTIVE_NOT_RECRUITING
PHASE2
Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40%
NCT04986202
COMPLETED
PHASE2/PHASE3
Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study
NCT06111768
ACTIVE_NOT_RECRUITING
PHASE2
Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
NCT06108414
RECRUITING
PHASE4