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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Los Angeles Biomedical Research Institute
Sponsor:
Information provided by (Responsible Party):
Matthew J. Budoff, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT02090075
First received: March 16, 2014
Last updated: March 17, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • Coronary Artery Calcium (CAC) score [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • coronary plaque on CT angiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 66
Study Start Date: May 2014
Estimated Primary Completion Date: July 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090075

Contacts
Contact: Matthew J Budoff, MD 3102224107 mbudoff@labiomed.org

Sponsors and Collaborators
Los Angeles Biomedical Research Institute
  More Information

No publications provided

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
Study First Received: March 16, 2014
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Los Angeles Biomedical Research Institute:
cardiac Computed tomography
coronary calcification
intervention
warfarin
apixaban

Additional relevant MeSH terms:
Warfarin
Atrial Fibrillation
Calcinosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Calcium Metabolism Disorders
Metabolic Diseases
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014