RIvoraxaban in Mitral Stenosis

PHASE3TerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 22, 2019

Primary Completion Date

May 22, 2021

Study Completion Date

August 14, 2021

Conditions
Mitral StenosisRheumatic Heart DiseaseAtrial FibrillationAnticoagulant Adverse Reaction
Interventions
DRUG

Rivaroxaban

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

DRUG

Warfarin

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.

Trial Locations (1)

1995614331

Rajaie Cardiovascular Medical and Research Center, Tehran

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute for Medical research and Development (NIMAD)

UNKNOWN

collaborator

Abidi Pharmaceuticals

OTHER

lead

Rajaie Cardiovascular Medical and Research Center

OTHER