Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque
Status:
Completed
Trial end date:
2017-04-05
Target enrollment:
Participant gender:
Summary
Vitamin K-antagonists (VKA) such as warfarin are the most widely used blood thinners for
irregular heart beats like atrial fibrillation. Several lines of evidence indicate, however,
that these agents also cause calcification of vessels (hardening of the vessels). Vascular
calcification is one of the recently revealed side-effects of warfarin therapy. We will be
randomizing 66 patients to either take warfarin or a new blood thinner that works without
affecting vitamin k (apixaban). Patients will undergo blood testing and a CT angiogram
(non-invasive angiogram) at the beginning of the study, and then be followed for one year
with quarterly visits including blood tests and given either warfarin or vitamin K. After one
year, they will undergo another CT angiogram and examination and blood tests and the effect
of apixaban and warfarin are tested to look at plaque and changes over time. Patients will be
consented in a private room and the risks and benefits will be explained. The risks include
the CT angiogram and the possibility of either remaining on warfarin therapy for another year
(standard of care) or taking a medicine that doesn't require monitoring (apixaban) for one
year. The CT angiograms will require some contrast and some radiation dose, which will be
minimized as much as possible. A cardiologist will be present during each CT angiogram to
minimize risk and ensure patient safety.
Phase:
Phase 4
Details
Lead Sponsor:
Los Angeles Biomedical Research Institute Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center