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

NCT02090075 | Completed Phase 4 Results

• 1 other identifier: 21183-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

cardiac Computed tomography; coronary calcification; intervention; warfarin; apixaban

Outcome Measures

Primary Outcomes (1)

• Coronary Artery Calcium (CAC) Score

  amount of calcification measured by Agatston Score. The range of values for the Agatston score is 0-10000. Higher score is worse outcome.

  1 year

Secondary Outcomes (1)

• Coronary Plaque on CT Angiography

  1 year

Study Arms (2)

apixaban

ACTIVE COMPARATOR

apixaban 5 mg or 2.5 mg po bid

Drug: apixaban

warfarin

PLACEBO COMPARATOR

warfarin with target INR of 2-3

Drug: warfarin

Interventions

apixaban DRUG

5 po or 2.5 po bid.

Also known as: eliquis

apixaban

warfarin DRUG

Also known as: Coumadin

warfarin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients with atrial fibrillation or flutter
• Age 18-84 years
• Willingness to participate in the study and ability to sign informed consent.

You may not qualify if:

• Atrial fibrillation due to a reversible cause
• moderate or severe mitral stenosis
• 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
• Known allergy to iodinated contrast material
• pregnancy, women of childbearing potential unwilling to use adequate contraception.

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

Related Publications (1)

• Win TT, Nakanishi R, Osawa K, Li D, Susaria SS, Jayawardena E, Hamal S, Kim M, Broersen A, Kitslaar PH, Dailing C, Budoff MJ. Apixaban versus warfarin in evaluation of progression of atherosclerotic and calcified plaques (prospective randomized trial). Am Heart J. 2019 Jun;212:129-133. doi: 10.1016/j.ahj.2019.02.014. Epub 2019 Mar 13.

  PMID: 31002997 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixaban; Warfarin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr Matthew Budoff
• Organization: Los Angeles Biomedical Research Institute at Harbo

mbudoff@labiomed.org

3102224107

Study Officials

• Matthew Budoff, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 16, 2014
• First Posted: March 18, 2014
• Study Start: September 1, 2014
• Primary Completion: December 27, 2016
• Study Completion: April 5, 2017
• Last Updated: April 23, 2019
• Results First Posted: April 23, 2019

Record last verified: 2019-03

Locations

US (1)