Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque

• Status: Completed
• Trial end date: 2017-04-05
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Treatments: Apixaban; Warfarin

Criteria

Inclusion Criteria:

• Eligible patients with atrial fibrillation or flutter

• Age 18-84 years

• Willingness to participate in the study and ability to sign informed consent.

Exclusion Criteria:

• Atrial fibrillation due to a reversible cause

• moderate or severe mitral stenosis

• conditions other than atrial fibrillation that require anticoagulation (e.g., a prosthetic heart valve)

• A need for aspirin at a dose of >165 mg a day or for both aspirin and P2Y-inhibitor

• Serious bleeding event in the previous 6 months or a high risk of bleeding (eg, active peptic ulcer disease)

• a platelet count of <100,000/mm3 or hemoglobin level of <10 g/dL

• stroke within the previous 10 days

• documented hemorrhagic tendencies, or blood dyscrasias

• Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of <50 ml per minute)

• Weight in excess of 325 pounds

• Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension (systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg)

• History of active malignancy requiring concurrent chemotherapy

• Known allergy to iodinated contrast material

• pregnancy, women of childbearing potential unwilling to use adequate contraception.