Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium

NCT02376010 | Completed Phase 4 Results

• 1 other identifier: 21429
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Coronary Artery Calcium (Serial Calcium Scans)

  serial calcium scans

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (2)

rivaroxaban

ACTIVE COMPARATOR

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

Drug: rivaroxaban

warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

rivaroxaban DRUG

rivaroxaban

Warfarin DRUG

warfarin

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Study Sites (1)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Matthew Budoff
• Organization: Lundquist Institute

mbudoff@lundquist.org

3102224107

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 3, 2015
• Study Start: April 2, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 15, 2024
• Results First Posted: July 22, 2021

Record last verified: 2024-10

Locations

US (1)