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NCT06187311: REVISE-AF

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

Recruiting now Phase 4 Last updated 5 January 2024
What this trial tests

Phase 4 trial testing Rivaroxaban 20 MG in Atrial Fibrillation in 940 participants. Currently enrolling.

Timeline
12 January 2023
Primary endpoint
30 June 2026
30 June 2027

Quick facts

Lead sponsorKorea University Anam Hospital
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment940
Start date12 January 2023
Primary completion30 June 2026
Estimated completion30 June 2027
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Korea University Anam Hospital

Who can join

Adults 19 to 99, any sex, with Atrial Fibrillation or Anticoagulant Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Rivaroxaban 20 MG

Trials testing the same drug.

Other recruiting trials for Atrial Fibrillation

Currently open trials in the same condition.

Other Korea University Anam Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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