Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium (NCT02376010) | Clinical Trial Compass
CompletedPhase 4
Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium
United States110 participantsStarted 2015-04-02
Plain-language 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.
Who can participate
Age range
18 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Eligible patients with atrial fibrillation at enrollment or two or more episodes of atrial fibrillation or flutter, as documented by electrocardiography, at least 2 weeks apart in the 12 months before enrollment
. Age 18-84
. On Warfarin for 6 months prior to enrollment at a stable dose.
. Willingness to participate in the study and ability to sign informed consent
. Minimum CAC score of 10
Exclusion criteria
. Atrial fibrillation due to a reversible cause, moderate or severe mitral stenosis, or conditions other than atrial fibrillation that require anticoagulation (e.g., a prosthetic heart valve)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coronary Artery Calcium (Serial Calcium Scans)
Timeframe: 1 year
Trial details
NCT IDNCT02376010
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
. A need for aspirin at a dose of \>165 mg a day or for both aspirin and clopidogrel,
. Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of \<50 ml per minute).
. 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)
. 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.