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Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02090075
First Posted: March 18, 2014
Last Update Posted: May 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matthew J. Budoff, Los Angeles Biomedical Research Institute
  Purpose
Vitamin K-antagonists (VKA) such as warfarin are the most widely used blood thinners for irregular heart beats like atrial fibrillation. Several lines of evidence indicate, however, that these agents also cause calcification of vessels (hardening of the vessels). Vascular calcification is one of the recently revealed side-effects of warfarin therapy. We will be randomizing 66 patients to either take warfarin or a new blood thinner that works without affecting vitamin k (apixaban). Patients will undergo blood testing and a CT angiogram (non-invasive angiogram) at the beginning of the study, and then be followed for one year with quarterly visits including blood tests and given either warfarin or vitamin K. After one year, they will undergo another CT angiogram and examination and blood tests and the effect of apixaban and warfarin are tested to look at plaque and changes over time. Patients will be consented in a private room and the risks and benefits will be explained. The risks include the CT angiogram and the possibility of either remaining on warfarin therapy for another year (standard of care) or taking a medicine that doesn't require monitoring (apixaban) for one year. The CT angiograms will require some contrast and some radiation dose, which will be minimized as much as possible. A cardiologist will be present during each CT angiogram to minimize risk and ensure patient safety.

Condition Intervention Phase
Atrial Fibrillation Drug: apixaban Drug: warfarin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque

Resource links provided by NLM:


Further study details as provided by Matthew J. Budoff, Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Coronary Artery Calcium (CAC) score [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • coronary plaque on CT angiography [ Time Frame: 1 year ]
    To evaluate if treatment with apixaban therapy, as compared to warfarin therapy, will modify the progression, regression and stabilization of coronary atherosclerosis. Modifications will include differences in plaque volume, composition and arterial remodeling; as well as new atherosclerosis formation


Enrollment: 64
Study Start Date: September 2014
Study Completion Date: April 5, 2017
Primary Completion Date: December 27, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: apixaban
apixaban 5 mg or 2.5 mg po bid
Drug: apixaban
5 po or 2.5 po bid.
Other Name: eliquis
Placebo Comparator: warfarin
warfarin with target INR of 2-3
Drug: warfarin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients with atrial fibrillation or flutter at enrollment or two or more episodes of atrial fibrillation, as documented by electrocardiography, at least 2 weeks apart in the 12 months before enrollment; Age 18-84 years; Willingness to participate in the study and ability to sign informed consent.

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);A need for aspirin at a dose of >165 mg a day or for both aspirin and P2Y-inhibitor; 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) Renal insufficiency (serum creatinine level of 12.5 mg per deciliter or calculated creatinine clearance of <50 ml per minute); 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, women of childbearing potential unwilling to use adequate contraception.
  Contacts and Locations
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): NCT02090075


Locations
United States, California
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Investigators
Principal Investigator: Matthew Budoff, MD Los Angeles Biomedical Research Institute
  More Information

Responsible Party: Matthew J. Budoff, Professor of Medicine, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT02090075     History of Changes
Other Study ID Numbers: 21183-01
First Submitted: March 16, 2014
First Posted: March 18, 2014
Last Update Posted: May 1, 2017
Last Verified: April 2017

Keywords provided by Matthew J. Budoff, Los Angeles Biomedical Research Institute:
cardiac Computed tomography
coronary calcification
intervention
warfarin
apixaban

Additional relevant MeSH terms:
Atrial Fibrillation
Calcinosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Calcium Metabolism Disorders
Metabolic Diseases
Apixaban
Warfarin
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action