MedTrace Logo

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

NCT04696120 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-01-20

No results posted yet for this study

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

Conditions

Interventions

DRUG

Apixaban

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

DRUG

Placebo

All patients who are assigned to placebo group will receive placebo

Sponsors & Collaborators

  • Dt&Sanomedics

    collaborator INDUSTRY

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Eung Ju Kim, MD, PhD. · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2022-08-30
Completion
2023-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04696120 on ClinicalTrials.gov