drugset / Trial / NCT02376010

Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

NCT02376010

RandomizedParallel-groupOpen-labelPrevention

Summary

Current oral anti-coagulation for atrial fibrillation is most commonly performed with warfarin. Warfarin is a vitamin K antagonist that has been shown in non-randomized trials to increase vascular calcification. Increased vascular calcification has been tied to increased cardiovascular events (CVE). This study will randomize patients currently taking warfarin to either continue on warfarin or be switched to rivaroxaban. Rivaroxaban is an oral anti-coagulant that works by inhibiting Factor Xa, and has no interaction with vitamin K. This study is a randomized, open label study that will randomize 120 patients and have them undergo blood tests and a calcium scan at baseline, and again after 12 months. Patients will be seen quarterly for examinations, safety checks and supply of rivaroxaban, as well as follow up INR testing for warfarin.

Timeline

Start
2015-04-02
Primary completion
2018-04-01
Completion
2018-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rivaroxaban Other / unclassified 15 mg Oral
Comparator Rivaroxaban Other / unclassified 20 mg Oral
Comparator Warfarin Small molecule Oral

Indications