The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
- Conditions
- ASCVD
- Registration Number
- NCT04197453
- Lead Sponsor
- Amgen
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 752
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incident event rate for the composite of all-cause mortality, non-fatal myocardial infarction (MI), and non-fatal ischemic stroke (IS). Through study completion, a minimum of 4.5 years and maximum of 5 years Number of incident all-cause deaths, non-fatal MI, and non-fatal IS events (whichever occurs first) divided by the person-time at risk
- Secondary Outcome Measures
Name Time Method Incident event rate for all-cause mortality Through study completion, a minimum of 4.5 years and maximum of 5 years Number of all-cause deaths divided by the person-time at risk
Incident event rate for non-fatal IS Through study completion, a minimum of 4.5 years and maximum of 5 years Number incident non-fatal IS events divided by the person-time at risk
Incident event rate for transient ischemic attack (TIA) Through study completion, a minimum of 4.5 years and maximum of 5 years Number of incident TIA events divided by the person-time at risk
Incident event rate for cardiovascular death Through study completion, a minimum of 4.5 years and maximum of 5 years Number of cardiovascular deaths divided by the person-time at risk
Incident event rate for non-fatal MI Through study completion, a minimum of 4.5 years and maximum of 5 years Number of incident non-fatal MI events divided by the person-time at risk
Incident rate of coronary or peripheral or carotid revascularication procedures Through study completion, a minimum of 4.5 years and maximum of 5 years Number of incident coronary or peripherial or carotid revascularization procedures
Longitudinal patterns of lipid control, use of and persistence with lipid lowering therapies (LLT) including statins, ezetimibe, and PCSK9 inhibitors Through study completion, a minimum of 4.5 years and maximum of 5 years Describe patterns of lipid control and LLT's over time
The strengths and limitations of data harvested directly from electronic health record (EHR) systems as compared with prospectively collected information Through study completion, a minimum of 4.5 years and maximum of 5 years 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.
Incident event rate for major adverse limb events (MALE) including amputation Through study completion, a minimum of 4.5 years and maximum of 5 years 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).
Incident event rate for unstable angina (UA) Through study completion, a minimum of 4.5 years and maximum of 5 years Number of incident UA events divided by the person-time at risk
Trial Locations
- Locations (162)
Discovery Clinical Services Ltd
🇨🇦Victoria, British Columbia, Canada
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Sewa Ram Singal Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States
Multicare Institute for Research and Innovation
🇺🇸Puyallup, Washington, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Missouri Cardiovascular Specialists
🇺🇸Columbia, Missouri, United States
Accel Research Sites
🇺🇸Atlanta, Georgia, United States
John H Stroger Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Premier Cardiovascular
🇺🇸Dayton, Ohio, United States
Heart House Research Foundation
🇺🇸Springfield, Ohio, United States
CardioVoyage
🇺🇸McKinney, Texas, United States
Washington University
🇺🇸Seattle, Washington, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Northwest Houston Cardiology
🇺🇸Houston, Texas, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Saint Vincent Heart Center
🇺🇸Indianapolis, Indiana, United States
Consano Clinical Research
🇺🇸San Antonio, Texas, United States
San Antonio Endovascular and Heart Institute
🇺🇸San Antonio, Texas, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Ocala Cardiovascular Research
🇺🇸Ocala, Florida, United States
Jackson Heart
🇺🇸Jackson, Mississippi, United States
Willis Knighton Cardiology
🇺🇸Shreveport, Louisiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Baptist Heart Specialists
🇺🇸Jacksonville Beach, Florida, United States
McLaren Health
🇺🇸Bay City, Michigan, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Clinical Trials of America Inc
🇺🇸Monroe, Louisiana, United States
TidalHealth Peninsula Regional, Inc
🇺🇸Salisbury, Maryland, United States
Bay Area Cardiology
🇺🇸Brandon, Florida, United States
MedStar Health Research Institute Chesapeake Cardiovascular Associates
🇺🇸Hyattsville, Maryland, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Albany Medical College
🇺🇸Albany, New York, United States
Advanced Heart Care LLC
🇺🇸Bridgewater, New Jersey, United States
Marshall Cardiology
🇺🇸Huntington, West Virginia, United States
Upstate Cardiology
🇺🇸Greenville, South Carolina, United States
Columbia Heart
🇺🇸Columbia, South Carolina, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Advanced Cardiology LLC
🇺🇸Cedar Knolls, New Jersey, United States
Parkway Cardiology Associates
🇺🇸Oak Ridge, Tennessee, United States
Oakville Cardiovascular Research Limited Partnership
🇨🇦Oakville, Ontario, Canada
AnMed Health
🇺🇸Anderson, South Carolina, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Genesis Clinical Research Inc
🇺🇸Tampa, Florida, United States
Methodist Physicians Clinic Heart Consultants
🇺🇸Omaha, Nebraska, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cardiovascular Research Foundation of Southern California
🇺🇸Beverly Hills, California, United States
Mercy Gilbert Medical Center
🇺🇸Gilbert, Arizona, United States
Old Pueblo Cardiology
🇺🇸Tucson, Arizona, United States
Millennium Clinical Trials
🇺🇸Thousand Oaks, California, United States
Eisenhower Desert Cardiology Center
🇺🇸Rancho Mirage, 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
Central Coast Cardiovascular
🇺🇸Ventura, California, United States
Cardiology Associates of Fairfield County, PC
🇺🇸Stamford, Connecticut, United States
Holy Cross Hospital Inc
🇺🇸Fort Lauderdale, Florida, United States
Southwest Florida Research LLC
🇺🇸Naples, Florida, United States
Cardiology Consultants
🇺🇸Pensacola, Florida, United States
Palm Harbor Medical Associates
🇺🇸Palm Harbor, Florida, United States
Northwest Heart Clinical Research LLC
🇺🇸Arlington Heights, Illinois, United States
Albany Internal Medicine
🇺🇸Albany, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Evanston Premier Healthcare Research LLC
🇺🇸Evanston, Illinois, United States
First Georgia Physicians Group
🇺🇸Fayetteville, Georgia, United States
Prairie Cardiovascular Consultants
🇺🇸Springfield, Illinois, United States
Reid Physician Associates
🇺🇸Richmond, Indiana, United States
Midwest Cardiovascular Research Foundation
🇺🇸Davenport, Iowa, United States
Midwest Heart and Vascular Specialists
🇺🇸Overland Park, Kansas, United States
MercyOne Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Premier Medical Group
🇺🇸Owensboro, Kentucky, United States
Heart Clinic of Hammond
🇺🇸Hammond, Louisiana, United States
Louisiana Heart Center
🇺🇸Slidell, Louisiana, United States
Saint Louis Heart and Vascular PC
🇺🇸Saint Louis, Missouri, United States
Palm Research Center Inc
🇺🇸Las Vegas, Nevada, United States
Virtua Health, Inc.
🇺🇸Voorhees, New Jersey, United States
Long Island Cardiovascular Consultants
🇺🇸Lake Success, New York, United States
Bassett Healthcare
🇺🇸Cooperstown, New York, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
SJH Cardiology Associates
🇺🇸Liverpool, New York, United States
Circuit Clinic
🇺🇸Orchard Park, New York, United States
Montefiore Medical Center - Bronx
🇺🇸Bronx, New York, United States
DiGiovanna Institute for Medical Education and Research
🇺🇸North Massapequa, New York, United States
Northwell Health
🇺🇸New York, New York, United States
Duke Heart Center Clinical Research
🇺🇸Durham, North Carolina, United States
Saratoga Clinical Research, LLC
🇺🇸Saratoga Springs, New York, United States
Cone Health
🇺🇸Greensboro, North Carolina, United States
Vidant Cardiology
🇺🇸Greenville, North Carolina, United States
Novant Health Heart and Vascular Institute
🇺🇸Monroe, North Carolina, United States
Coastal Carolina Health Care PA
🇺🇸New Bern, North Carolina, United States
WakeMed
🇺🇸Raleigh, North Carolina, United States
Pinehurst Medical Clinic, Inc
🇺🇸Pinehurst, North Carolina, United States
Sanford Cardiology
🇺🇸Sanford, North Carolina, United States
PMG Research of Piedmont HealthCare
🇺🇸Statesville, North Carolina, United States
The Ohio State University, Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Kettering Medical Center
🇺🇸Kettering, Ohio, United States
Central Oklahoma Early Detection Center
🇺🇸Edmond, Oklahoma, United States
Saint Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Lynn Institute of Tulsa
🇺🇸Tulsa, Oklahoma, United States
Central PA Physicians Group
🇺🇸Altoona, Pennsylvania, United States
Chambersburg Hospital
🇺🇸Chambersburg, Pennsylvania, United States
Capital Area Research LLC
🇺🇸Camp Hill, Pennsylvania, United States
Doylestown Health Cardiology
🇺🇸Doylestown, Pennsylvania, United States
The Heart Group of Lancaster General Health
🇺🇸Lancaster, Pennsylvania, United States
Kent Hospital
🇺🇸Warwick, Rhode Island, United States
Diagnostic Cardiology Group
🇺🇸Chattanooga, Tennessee, United States
Monument Health Clinical Research
🇺🇸Rapid City, South Dakota, United States
Stern Cardiovascular Foundation Inc
🇺🇸Germantown, Tennessee, United States
Thyroid Endocrinology and Diabetes
🇺🇸Dallas, Texas, United States
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Texas Institute of Cardiology
🇺🇸McKinney, Texas, United States
North Dallas Research Associates
🇺🇸McKinney, Texas, United States
Permian Research Foundation
🇺🇸Odessa, Texas, United States
Southern Endocrinology Associates PA
🇺🇸Mesquite, Texas, United States
Village Medical Centers
🇺🇸The Woodlands, Texas, United States
Northwest Houston Heart Center
🇺🇸Tomball, Texas, United States
Stroobants Cardiovascular Center
🇺🇸Lynchburg, Virginia, United States
Tyler Cardiovascular Consultants
🇺🇸Tyler, Texas, United States
Virginia Heart
🇺🇸Falls Church, Virginia, United States
Cardiology Consultants of Danville, Inc
🇺🇸Danville, Virginia, United States
Cardiovascular Associates of Virginia
🇺🇸Midlothian, Virginia, United States
Tidewater Physicians Multispecialty Group Clinical Research
🇺🇸Newport News, Virginia, United States
Carient Heart and Vascular
🇺🇸Manassas, Virginia, United States
York Clinical Research LLC
🇺🇸Norfolk, Virginia, United States
Fraser River Endocrinology
🇨🇦Surrey, British Columbia, Canada
Cardio Metabolic Collaborative Clinic
🇨🇦Victoria, British Columbia, Canada
South Sherbrook Health Centre and Pharmacy
🇨🇦Winnipeg, Manitoba, Canada
Brampton Clinical Trials
🇨🇦Brampton, Ontario, Canada
Rhema Research Institute
🇨🇦Owen Sound, Ontario, Canada
Cambridge Cardiac Care Centre
🇨🇦Cambridge, Ontario, Canada
Saul Vizel Professional Medicine Corporation â€" Vizel Cardiac Research
🇨🇦Cambridge, Ontario, Canada
Curnew Medicine Professional Corporation
🇨🇦Hamilton, Ontario, Canada
Partners in Advanced Cardiac Evaluation
🇨🇦Newmarket, Ontario, Canada
Heart Health Institute Research Incorporated
🇨🇦Scarborough, Ontario, Canada
Cardiovasular Clinical Research Organization Limited
🇨🇦Sudbury, Ontario, Canada
Mohan Babapulle Medicine Professional Corporation
🇨🇦Waterloo, Ontario, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
McGill University Health Centre - Montreal General Hospital
🇨🇦Montreal, Quebec, Canada
CardioVasc HR Incorporated
🇨🇦St Jean sur Richelieu, Quebec, Canada
Applied Medical Informatics Research Incorporated
🇨🇦Montreal, Quebec, Canada
University of Colorado Memorial Health System
🇺🇸Colorado Springs, Colorado, United States
Ascension St John Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
Oklahoma State University Health Science Center
🇺🇸Tulsa, Oklahoma, United States
Winnipeg Clinic
🇨🇦Winnipeg, Manitoba, Canada
Cardio 1
🇨🇦Winnipeg, Manitoba, Canada
Grace Research LLC
🇺🇸Shreveport, Louisiana, United States
Cox Medical Centers
🇺🇸Springfield, Missouri, United States
University Medical Center-New Orleans
🇺🇸New Orleans, Louisiana, United States
Ochsner Health Systems
🇺🇸New Orleans, Louisiana, United States
PMG Research of Charleston
🇺🇸Charleston, South Carolina, United States
Seton Heart Institute
🇺🇸Austin, Texas, United States
The Cardiac and Vascular Institute Research
🇺🇸Gainesville, Florida, United States
Interventional Cardiac Consultants
🇺🇸Trinity, Florida, United States
Los Alamitos Cardiovascular
🇺🇸Los Alamitos, California, United States