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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rivaroxaban | Active Comparator | rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR) |
|
| warfarin | Active Comparator | warfarin orally once a day, titrated to INR of 2-3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rivaroxaban | Drug |
| ||
| Warfarin |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Artery Calcium (Serial Calcium Scans) | serial calcium scans | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Atherosclerotic Plaque (Measures of Total Atherosclerosis Plaque on Serial CCTA) | measures of total atherosclerosis plaque on serial CCTA | 1 year |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Biomedical Research Institute | Torrance | California | 90502 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rivaroxaban | rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR) rivaroxaban |
| FG001 | Warfarin | warfarin orally once a day, titrated to INR of 2-3 Warfarin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rivaroxaban | rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR) rivaroxaban |
| BG001 | Warfarin | warfarin orally once a day, titrated to INR of 2-3 Warfarin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Coronary Artery Calcium (Serial Calcium Scans) | serial calcium scans | patients completed second scan with interpretable data | Posted | Median | Inter-Quartile Range | mm cubed | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rivaroxaban | rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR) rivaroxaban |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| minor bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Budoff | Lundquist Institute | 3102224107 | mbudoff@lundquist.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2015 | Jul 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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randomized controlled trial, with blinded randomization to one of two groups.
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Atherosclerotic Plaque (Measures of Total Atherosclerosis Plaque on Serial CCTA) | measures of total atherosclerosis plaque on serial CCTA | volume of plaque in patients completing study | Posted | Median | Inter-Quartile Range | mm cubed | 1 year |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 1 |
| 46 |
| EG001 | Warfarin | warfarin orally once a day, titrated to INR of 2-3 Warfarin | 0 | 51 | 0 | 51 | 2 | 51 |
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| D003327 |
| Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |