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Trial record 52 of 156 for:    warfarin AND Vitamin K

Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

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ClinicalTrials.gov Identifier: NCT02376010
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: rivaroxaban Drug: Warfarin Phase 4

Detailed Description:
Rivaroxaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with warfarin. The rate of myocardial infarction was 9% lower in the rivaroxaban group than in the warfarin group in the Rocket AF study and similarly the myocardial infarction rate was 12% lower in the apixaban group in Aristotle, but the difference was not significant in either trial. The potential of long term benefit by avoiding VKA therapy may be much greater for a CV event reduction. The study proposed will evaluate markers of CAC progression and atherosclerosis development, which have long term outcome data supporting that slowing these processes will be associated with lower CV events.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium
Actual Study Start Date : April 2, 2015
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: rivaroxaban
rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)
Drug: rivaroxaban
Active Comparator: warfarin
warfarin orally once a day, titrated to INR of 2-3
Drug: Warfarin



Primary Outcome Measures :
  1. coronary artery calcium (serial calcium scans) [ Time Frame: 1 year ]
    serial calcium scans


Secondary Outcome Measures :
  1. atherosclerotic plaque (measures of total atherosclerosis plaque on serial CCTA) [ Time Frame: 1 year ]
    measures of total atherosclerosis plaque on serial CCTA



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. 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
  2. Age 18-84
  3. On Warfarin for 6 months prior to enrollment at a stable dose.
  4. Willingness to participate in the study and ability to sign informed consent
  5. Minimum CAC score of 10

Key Exclusion Criteria:

  1. 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)
  2. Prior apixaban, dabigatran, rivaroxaban use.
  3. A need for aspirin at a dose of >165 mg a day or for both aspirin and clopidogrel,
  4. Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of <50 ml per minute).
  5. 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)
  6. Weight in excess of 325 pounds
  7. Resting hypotension (systolic blood pressure of <90mmHg) or resting hypertension (systolic blood pressure of >170mmHg or diastolic blood pressure of >110 mmHg).
  8. History of active malignancy requiring concurrent chemotherapy.
  9. Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the principal investigator is likely to affect the subject's ability to complete the study.
  10. Known allergy to iodinated contrast material
  11. Pregnancy or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376010


Locations
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United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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Responsible Party: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT02376010     History of Changes
Other Study ID Numbers: 21429
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: March 2017
Keywords provided by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:
atherosclerosis
coronary artery disease
cardiac CT
computed tomographic angiography
Additional relevant MeSH terms:
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Warfarin
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action