RIvoraxaban in Mitral Stenosis

• Status: Terminated
• Trial end date: 2021-08-14
• Target enrollment: 0
• Participant gender: All

Summary

In this randomized controlled clinical trial, patients with moderate to severe mitral valve stenosis (MS) and atrial fibrillation (AF) will be enrolled into the study.Participants will be divided into two groups based on the anticoagulation regimen type. The intervention group will receive rivaroxaban and the control group will be given warfarin. All patients will be observed closely during a period of one year. Through the follow up, embolic events and hemorrhagic complications will be recorded in both groups. In addition, patients in both group will undergo a baseline magnetic resonance imaging (MRI) and an MRI after one-year follow up, by which the silent embolic events will be compared in both groups.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rajaie cardiovascular medical & research center; Rajaie Cardiovascular Medical and Research Center
• Collaborators: Abidi Company; Abidi Pharmaceuticals; National Institute for Medical research and Development (NIMAD)
• Treatments: Factor Xa Inhibitors; Rivaroxaban; Vitamin K; Vitamin K 1; Warfarin

Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Men and women ≥ 18 year-old

4. 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.

5. Ability to take oral medication and be willing to adhere to the rivaroxaban regimen

Exclusion Criteria:

1. Left atrial clot

2. Severe renal dysfunction (creatinine clearance [CrCl] <15 mL/min), subjects with

3. A condition associated with a high risk of bleeding

4. Allergic to rivaroxabn/warfarin