cvMOBIUS is a North American registry of patients with ASCVD aimed at understanding patterns of care in ASCVD while evaluating the real world effectiveness of PCSK9 inhibitors.
The purpose of this registry is to evaluate the effectiveness of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors (PCSK9i) to reduce cardiovascular events among subjects presenting with a recent atherosclerotic cardiovascular disease (ASCVD) event in real-world practice. A total of 8500 patients with a recent cardiovascular event who are likely to be eligible for non-statin lipid lowering therapy will be enrolled and followed prospectively for five years. In addition, the study will assess longitudinal patterns of lipid control, clinical outcomes, and LLT including statins, ezetimibe, and PCSK9 inhibitors in adults with an ASCVD event and/or revascularization. This study will also compare the clinical characteristics and outcomes of subjects enrolled in both arms of the registry to understand the strengths and limitations of data harvested directly from electronic health record (EHR) systems as compared with prospectively collected information.
Study Type
OBSERVATIONAL
Enrollment
752
Incident event rate for the composite of all-cause mortality, non-fatal myocardial infarction (MI), and non-fatal ischemic stroke (IS).
Number of incident all-cause deaths, non-fatal MI, and non-fatal IS events (whichever occurs first) divided by the person-time at risk
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for all-cause mortality
Number of all-cause deaths divided by the person-time at risk
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for non-fatal MI
Number of incident non-fatal MI events divided by the person-time at risk
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for non-fatal IS
Number incident non-fatal IS events divided by the person-time at risk
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident rate of coronary or peripheral or carotid revascularication procedures
Number of incident coronary or peripherial or carotid revascularization procedures
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for major adverse limb events (MALE) including amputation
Number of incident MALE events divided by the person-time at risk. MALE is defined as the composite of ALI, major amputation (above the knee or below the knee, excluding forefoot or toe), or urgent revascularization (thrombolysis or urgent vascular intervention for ischemia).
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, United States
Old Pueblo Cardiology
Tucson, Arizona, United States
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States
Los Alamitos Cardiovascular
Los Alamitos, California, United States
Consortium of Attending Physicians for Research Investigations LLC
Los Angeles, California, United States
Nanavati Critical Care Cardiology Clinic
National City, California, United States
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, United States
San Diego Cardiac Center
San Diego, California, United States
...and 154 more locations
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for cardiovascular death
Number of cardiovascular deaths divided by the person-time at risk
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for transient ischemic attack (TIA)
Number of incident TIA events divided by the person-time at risk
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for unstable angina (UA)
Number of incident UA events divided by the person-time at risk
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
Longitudinal patterns of lipid control, use of and persistence with lipid lowering therapies (LLT) including statins, ezetimibe, and PCSK9 inhibitors
Describe patterns of lipid control and LLT's over time
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years
The strengths and limitations of data harvested directly from electronic health record (EHR) systems as compared with prospectively collected information
Describe and compare clinical characteristics, ASCVD events, patterns of lipid control, and use of LLT's assessed via prospective data collection to those captured directly via an EHR data harvest.
Time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years