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

Study acronym: REVISE-AF
StatusRecruiting
PhasePhase 4
Started
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Record status
This record was last updated January 5, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Interventions: Rivaroxaban 15 MG versus Rivaroxaban 20 MG (Drug) to Rivaroxaban 15 MG (Drug), Rivaroxaban 20 MG (Drug)
    • Secondary endpoints revised (9)
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06187311
Lead Sponsor Korea University Anam Hospital
Conditions
(from sponsor)		 Atrial Fibrillation, Anticoagulant Adverse Reaction
Related terms Atrial Fibrillation
Enrollment 940 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov