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

Summary

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.

Timeline

Start

2023-01-12

Primary completion

2026-06-30

Completion

2027-06-30

Publications

• Results Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
• Results Hori M, Matsumoto M, Tanahashi N, Momomura S, Uchiyama S, Goto S, Izumi T, Koretsune Y, Kajikawa M, Kato M, Ueda H, Iwamoto K, Tajiri M; J-ROCKET AF study investigators. Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation - the J-ROCKET AF study -. Circ J. 2012;76(9):2104-11. doi: 10.1253/circj.cj-12-0454. Epub 2012 Jun 5.
• Results Cho MS, Yun JE, Park JJ, Kim YJ, Lee J, Kim H, Park DW, Nam GB. Outcomes After Use of Standard- and Low-Dose Non-Vitamin K Oral Anticoagulants in Asian Patients With Atrial Fibrillation. Stroke. 2019 Jan;50(1):110-118. doi: 10.1161/STROKEAHA.118.023093. Epub 2018 Dec 3.
• Results Lin YC, Chien SC, Hsieh YC, Shih CM, Lin FY, Tsao NW, Chen CW, Kao YT, Chiang KH, Chen WT, Chien LN, Huang CY. Effectiveness and Safety of Standard- and Low-Dose Rivaroxaban in Asians With Atrial Fibrillation. J Am Coll Cardiol. 2018 Jul 31;72(5):477-485. doi: 10.1016/j.jacc.2018.04.084.
• Results Chan YH, Lee HF, Wang CL, Chang SH, Yeh CH, Chao TF, Yeh YH, Chen SA, Kuo CT. Comparisons of Rivaroxaban Following Different Dosage Criteria (ROCKET AF or J-ROCKET AF Trials) in Asian Patients With Atrial Fibrillation. J Am Heart Assoc. 2019 Nov 5;8(21):e013053. doi: 10.1161/JAHA.119.013053. Epub 2019 Oct 18.

Drugs

Indications