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NCT Number: NCT06187311

Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation

In this clinical trial, Rivaroxaban of standard dose (20mg) and reduced dose (15mg) will be administeted in non-valvular atrial fibrillation patients without severe renal dysfunction.

It is a randomized, open-label, and phase 4 clinical trial to compare and evaluate efficacy and safety of Rivaroxaban.

After obtaining informed consent to participate in this trial, screening is performed (Screening visit).

Screening includes baseline 12-lead electrocardiography and laboratory tests to exclude severe end-organ dysfunction (such as renal dysfunction, liver dysfunction, or anemia).

Baseline visits are available on the same day. After screening, subjects eligible for the trial will be randomly assigned (1:1 ratio) to Group 1 (15 mg of Rivaroxaban) or Group 2 (20 mg of Rivaroxaban) (Baseline visit).

The study drug (Rivaroxaban 15mg or 20mg daily) will be administered for 12 months.

During study period, a total of six visits (3,6,9,12 months) will be made, and follow-up test and outcome measurement will be done in each visit.

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Key information

Conditions

Atrial Fibrillation Anticoagulant Adverse Reaction Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location status: Recruiting

Location contact

Jong-il Choi, PhD

CONTACT

[email protected]

Joo Hee Jeong, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult men and women over 19 years of age when screening
  • A person whose atrial fibrillation has been confirmed by electrocardiogram during screening and baseline.
  • Anticoagulants for the prevention of stroke or systemic embolism For cases where medication is required, a person with a CHA2DS2-VASC score of 1 male/female 2 or more points (In case of one or more risk factors)
  • 4) CrCl (Creatinine Clearance) ≥50 ml/min
  • A person who voluntarily agrees in writing to this study

Exclusion criteria

  • Moderate mitral valve stenosis or mechanical artificial valve A person with a history of mechanical valve
  • Thyroid disease, terminal hypertrophy, brown cytoplasm, adrenal glands that affect the occurrence of atrial fibrillation A person accompanied by cortical disease, parathyroid disease, pancreatic disease, etc.
  • clinically significant bleeding (e.g., intracranial bleeding, gastrointestinal bleeding)
  • Clinical significance of liver disease related to blood coagulation disorder and Child Pugh B and C liver disease associated with the risk of bleeding
  • Patients with increased risk of bleeding due to the following conditions:
  • Gastrointestinal ulcer history within 6 months prior to random allocation
  • Intracranial or intracranial hemorrhage history within 6 months prior to random assignment
  • vascular abnormalities in the spinal cord or brain
  • History of brain, spinal cord or ophthalmic surgery within 30 days prior to random assignment

⑤ Brain or spinal cord injury within 6 months prior to random allocation

⑥ If you have esophageal varices or are suspected

⑦ Arteriovenous malformations

⑧ Vascular aneurysms

⑨ Patients with malignant tumors (Neoplasm) at high risk of bleeding

  • Stroke requiring combination of antiplatelet drugs when treating acute coronary syndrome or a patient with a history of transient ischemic attacks
  • Patients who are overreacting to the main or components of Rivaroxaban
  • Galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption a patient with genetic problems such as a disability
  • Patients with uncontrolled hypertension (systolic BP > 180 mm Hg or diastolic BP > 100 mm Hg)

Treatment and study plan

Rivaroxaban 20 MG

Drug

Subjects should take clinical trial drugs (20 mg of rivaroxaban) for each group of administration once a day for 12 months, according to random assignments.

Rivaroxaban 15 MG

Drug

Subjects should take clinical trial drugs (15 mg of rivaroxaban) for each group of administration once a day for 12 months, according to random assignments.

Primary outcomes

  1. Incident rate of major bleeding events

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.

    Incidence of 'major bleeding' defined by International Society on Thrombosis and Haemostasis (ISTH) : (i) hb decrease 2 g/dL or more, or (ii) bleeding requiring RBC transfusion 2 or more unites, (iii) bleeding at major organ (intracranial, intraocular, pericardial, intra-articular, retroperitoneal or intramuscular bleeding), (iv) bleeding that result lethal outcome

Secondary outcomes

  1. Occurrence of Stroke, Non-CNS systemic embolism, and vascular death death

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.

    Composite of stroke, Non-CNS systemic embolism, and vascular death death

  2. Occurrence of Stroke, Non-CNS systematic embolism, and myocardial infarction infaration, cardiovascular death

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.

    Composite of stroke, Non-CNS systemic embolism, and myocardial infarction

  3. Occurrence Stroke, Non-CNS systemic embolism, myocardial infarction (Myocardial infarction), (Cardio vascular death)

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy

    Individual incidence of stroke, Non-CNS systemic embolism, and myocardial infarction

  4. Occurrence of Severe Disabling Stroke

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.

    Severe stroke that results Modified Rankin Scale between 3 ~ 5

  5. All-cause motality

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.

    Death of any cuase

  6. Incidence of non-major clinically significant bleeding*

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy

    Any bleeding that do not fulfill 'major bleeding', but requring clinical intervention or unexpected medical visit, cease of study

  7. Abnormal reaction and drug abnormal reaction expression, vital sign, laboratory inspection, physical examination, 12-lead ECG

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy

  8. Number of unexpected medical service visit (Healthcare Utilization)

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.

    Any visit of medical service except routine visits

  9. Proportion of the drug taken during study period (Treatment persistence)

    Time frame: At baseline(Visit 2) and at 3 month, 6 month, 9 month, 12 month after the baseline visit, or at 1~3 month interval with regard to the subject's therapy.

    Maintenance of treatment to drug administration and treatment adherence

Study contacts

Contact information is provided by the study sponsor or research team.

Jong-il Choi, MD, PHD

CONTACT

[email protected]

02-920-6710

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

A Randomized, Open-labelled, Investigator-initiated Clinical Trial to Evaluate Efficacy and Safety of Rivaroxaban 15mg and 20mg in Patients With Non-valvular Atrial Fibrillation

Acronym: REVISE-AF

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 2, 2024
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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