| Company Name | Janssen Taiwan |
|---|---|
| Protocol Number | RIVAROXAFL3003 |
| Title of Study | An OPen-label, Randomized, Controlled, Multicenter Study ExplorIng TwO TreatmeNt StratEgiEs of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention 一項開放性、隨機分配、對照、多中心試驗，目的在於針對接受經皮冠狀動脈介入治療的心房纖維顫動受試者研究兩種Rivaroxaban治療策略以及一種劑量調整口服維生素K拮抗劑治療策略 |
| Primary Objective | Number of participants with clinically significant bleeding. Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention. 發生臨床顯著出血的受試者人數。臨床顯著出血包括心肌梗塞血栓溶解(TIMI)大出血、小出血及需進行醫療照護的出血。 |
| Number of Sites | 5 |
| Period of Study | From：03-Jul-2014 to：31-Mar-2016 |
| Number of Patients | 20 (Taiwan)/ 2,100 (Global)人 |
| IRB Approval Date | 27-May-2014 |
| Publication Plan / Date | 31-Mar-2017 |
