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Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

rivaroxaban

Warfarin

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring atherosclerosis, coronary artery disease, cardiac CT, computed tomographic angiography

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key 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

Key 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)
Prior apixaban, dabigatran, rivaroxaban use.
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.
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.
Known allergy to iodinated contrast material
Pregnancy or breast feeding

Sites / Locations

Los Angeles Biomedical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

rivaroxaban

warfarin

Arm Description

rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)

warfarin orally once a day, titrated to INR of 2-3

Outcomes

Primary Outcome Measures

Coronary Artery Calcium (Serial Calcium Scans)

serial calcium scans

Secondary Outcome Measures

Atherosclerotic Plaque (Measures of Total Atherosclerosis Plaque on Serial CCTA)

measures of total atherosclerosis plaque on serial CCTA

Full Information

NCT ID

NCT02376010

First Posted

February 24, 2015

Last Updated

July 21, 2021

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02376010

Brief Title

Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

Official Title

Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

April 2, 2015 (Actual)

Primary Completion Date

April 1, 2018 (Actual)

Study Completion Date

April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

Keywords

atherosclerosis, coronary artery disease, cardiac CT, computed tomographic angiography

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

randomized controlled trial, with blinded randomization to one of two groups.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rivaroxaban

Arm Type

Active Comparator

Arm Description

rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)

Arm Title

warfarin

Arm Type

Active Comparator

Arm Description

warfarin orally once a day, titrated to INR of 2-3

Intervention Type

Drug

Intervention Name(s)

rivaroxaban

Intervention Type

Drug

Intervention Name(s)

Warfarin

Primary Outcome Measure Information:

Title

Coronary Artery Calcium (Serial Calcium Scans)

Description

serial calcium scans

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Atherosclerotic Plaque (Measures of Total Atherosclerosis Plaque on Serial CCTA)

Description

measures of total atherosclerosis plaque on serial CCTA

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key 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 Key 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) Prior apixaban, dabigatran, rivaroxaban use. 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. 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. Known allergy to iodinated contrast material Pregnancy or breast feeding

Facility Information:

Facility Name

Los Angeles Biomedical Research Institute

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

12. IPD Sharing Statement

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Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

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