RIvoraxaban in Mitral Stenosis (RISE MS)
Mitral Stenosis, Rheumatic Heart Disease, Atrial Fibrillation
About this trial
This is an interventional treatment trial for Mitral Stenosis
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Men and women ≥ 18 year-old
- Diagnosed with moderate to severe mitral stenosis who have a history of AF of any duration documented by any electrical tracing within the prior 12 months and for which anticoagulation is indicated and planned for the duration of the study.
- Ability to take oral medication and be willing to adhere to the rivaroxaban regimen
Exclusion Criteria:
- Left atrial clot
- Severe renal dysfunction (creatinine clearance [CrCl] <15 mL/min), subjects with
- A condition associated with a high risk of bleeding
- Allergic to rivaroxabn/warfarin
Sites / Locations
- Rajaie Cardiovascular Medical and Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rivaroxaban
Warfarin
Rivaroxaban will be used as the anticoagulation drug for the intervention group. Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no approved antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food.
Warfarin will be used as the anticoagulation drug for the control group. Warfarin decreases blood clotting by blocking an enzyme called vitamin K epoxide reductase that reactivates vitamin K1. Without sufficient active vitamin K1, clotting factors II, VII, IX, and X have decreased clotting ability. The anticlotting protein C and protein S are also inhibited but to a lesser degree. A few days are required for full effect to occur and these effects can last for up to five days, and the final dose will be adjusted according to PT and related INR.