The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)

Stopped early

Conditions studied: ASCVD

In brief

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.

Key facts

Study ID

NCT04197453

Run by

Amgen

People needed

752

Starts

2019-12-06

Expected to finish

2020-12-21

Last updated by the study team

2021-10-15

Who can join

Age: 40 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age ≥ 40 years
• One or both of the following:
• Hospitalization for a clinical ASCVD event: acute (MI), UA, IS, or critical limb ischemia (CLI) within 18 months of enrollment NOTE: subjects must have been admitted to the hospital. Those who are admitted and discharged in less than 24 hours are eligible for the study. Subjects who have been admitted to the ER for a clinical ASCVD event and not admitted to the hospital are not eligible for enrollment.
• Coronary, peripheral, or carotid revascularization including percutaneous or surgical revascularization in the past 18 months Note: Revascularization procedures can occur in the inpatient or outpatient setting.
• One of the following:
• Low-density lipoprotein (LDL) ≥ 70 mg/dL (1.81 mmol/L) with no plans for immediate initiation or titration of statin therapy (Note: Subjects should not be enrolled into study during initiation/titration of statins until they have a stable LDL-C measurement > 4 weeks after their last statin change and no immediate plans for future titration).
• Newly started on PCSK9i after the index hospitalization/procedure and prior to enrollment (but no more than 6 months prior to enrollment) with pre-PCSK9i treatment LDL-C value available and known background LLT any time prior to PCSK9i initiation.
• Planned follow-up within the health system.

You may not qualify if…

• Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension)
• Lack of phone or email for contact
• Evidence of end stage renal disease (ESRD) or stage 5 chronic kidney disease (CKD)
• Anticipated life expectancy less than 6 months
• On a PCSK9i prior to their qualifying event; Note: Subjects with prior PCSK9i use occurring and ending before the 12-month period prior to enrollment and before the index ASCVD event will be considered for inclusion.
• EHR Arm Criteria:
• Subjects are eligible to be included in the "EHR arm" of the registry if they are:
• Adults age ≥ 40 years of age
• Have at least 1 inpatient or outpatient diagnosis of clinical ASCVD within 12 months prior to enrollment including CHD, ischemic cerebrovascular disease, atherosclerotic PAD, or prior coronary or peripheral or carotid revascularization.
• No exclusion criteria will be applied.

Where it is running

• 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
• Millennium Clinical Trials — Thousand Oaks, California, United States
• Central Coast Cardiovascular — Ventura, California, United States
• University of Colorado Memorial Health System — Colorado Springs, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Cardiology Associates of Fairfield County, PC — Stamford, Connecticut, United States
• Bay Area Cardiology — Brandon, Florida, United States
• Holy Cross Hospital Inc — Fort Lauderdale, Florida, United States
• The Cardiac and Vascular Institute Research — Gainesville, Florida, United States
• Baptist Heart Specialists — Jacksonville Beach, Florida, United States
• Southwest Florida Research LLC — Naples, Florida, United States
• Ocala Cardiovascular Research — Ocala, Florida, United States
• Palm Harbor Medical Associates — Palm Harbor, Florida, United States
• Cardiology Consultants — Pensacola, Florida, United States
• Genesis Clinical Research Inc — Tampa, Florida, United States
• Interventional Cardiac Consultants — Trinity, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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