Study Stopped
Sponsor decision
The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
cvMOBIUS
1 other identifier
observational
752
2 countries
164
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2019
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2019
CompletedStudy Start
First participant enrolled
December 6, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2020
CompletedOctober 15, 2021
October 1, 2021
1 year
December 5, 2019
October 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Through study completion, a minimum of 4.5 years and maximum of 5 years
Secondary Outcomes (10)
Incident event rate for all-cause mortality
Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for non-fatal MI
Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident event rate for non-fatal IS
Through study completion, a minimum of 4.5 years and maximum of 5 years
Incident rate of coronary or peripheral or carotid revascularication procedures
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
Through study completion, a minimum of 4.5 years and maximum of 5 years
- +5 more secondary outcomes
Study Arms (2)
Consented Arm
Subjects with a recent (within 18 months) hospitalization for myocardial infarction, unstable angina, ischemic stroke, or critical limb ischemia, and subjects undergoing coronary, peripheral, or carotid revascularization, including surgical and percutaneous revascularization, with an LDL-C greater than or equal to 70 mg/dL who may be eligible for PCSK9 inhibitor therapy.
Electronic Health Record (EHR) arm
Subjects with an inpatient or outpatient diagnosis of clinical ASCVD within the prior 12 months including coronary heart disease, ischemic cerebrovascular disease, atherosclerotic peripheral arterial disease, or prior coronary or peripheral or carotid revascularization.
Eligibility Criteria
Subjects with a recent ASCVD event or coronary, peripherial or carotid revascularization (in the prior 18 months). All subjects must have an LDL-C \>=70 mg/dL or have initiated a PCSK9 inhibitor in the 6 months prior to enrollment.
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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Duke Clinical Research Institutecollaborator
Study Sites (164)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Old Pueblo Cardiology
Tucson, Arizona, 85712, United States
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, 90210, United States
Los Alamitos Cardiovascular
Los Alamitos, California, 90720, United States
Consortium of Attending Physicians for Research Investigations LLC
Los Angeles, California, 90448, United States
Nanavati Critical Care Cardiology Clinic
National City, California, 91950, United States
Rancho Cucamonga Clinical Trials
Rancho Cucamonga, California, 91730, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, 92270, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
Millennium Clinical Trials
Thousand Oaks, California, 91360, United States
Central Coast Cardiovascular
Ventura, California, 93003, United States
University of Colorado Memorial Health System
Colorado Springs, Colorado, 80909, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Cardiology Associates of Fairfield County, PC
Stamford, Connecticut, 06905, United States
Bay Area Cardiology
Brandon, Florida, 33511, United States
Holy Cross Hospital Inc
Fort Lauderdale, Florida, 33308, United States
The Cardiac and Vascular Institute Research
Gainesville, Florida, 32605, United States
Baptist Heart Specialists
Jacksonville Beach, Florida, 32250, United States
Southwest Florida Research LLC
Naples, Florida, 34102, United States
Ocala Cardiovascular Research
Ocala, Florida, 34474, United States
Palm Harbor Medical Associates
Palm Harbor, Florida, 34684, United States
Cardiology Consultants
Pensacola, Florida, 32501, United States
Genesis Clinical Research Inc
Tampa, Florida, 33614, United States
Interventional Cardiac Consultants
Trinity, Florida, 34655, United States
Albany Internal Medicine
Albany, Georgia, 31707, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Accel Research Sites
Atlanta, Georgia, 30342, United States
First Georgia Physicians Group
Fayetteville, Georgia, 30214, United States
Northwest Heart Clinical Research LLC
Arlington Heights, Illinois, 60005, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Prairie Cardiovascular Consultants
Springfield, Illinois, 62701, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Saint Vincent Heart Center
Indianapolis, Indiana, 46290, United States
Reid Physician Associates
Richmond, Indiana, 47374, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803, United States
MercyOne Iowa Heart Center
West Des Moines, Iowa, 50266, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Midwest Heart and Vascular Specialists
Overland Park, Kansas, 66211, United States
Premier Medical Group
Owensboro, Kentucky, 42303, United States
Grace Research LLC
Bossier City, Louisiana, 71111, United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403, United States
Clinical Trials of America Inc
Monroe, Louisiana, 71201, United States
University Medical Center-New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner Health Systems
New Orleans, Louisiana, 70121, United States
Willis Knighton Cardiology
Shreveport, Louisiana, 71103, United States
Grace Research LLC
Shreveport, Louisiana, 71105, United States
Louisiana Heart Center
Slidell, Louisiana, 70458, United States
MedStar Health Research Institute Chesapeake Cardiovascular Associates
Hyattsville, Maryland, 20782, United States
TidalHealth Peninsula Regional, Inc
Salisbury, Maryland, 21804, United States
McLaren Health
Bay City, Michigan, 48708, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Michigan Heart
Ypsilanti, Michigan, 48197, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Jackson Heart
Jackson, Mississippi, 39216, United States
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Cox Medical Centers
Springfield, Missouri, 65807, United States
Washington University
St Louis, Missouri, 63110, United States
Saint Louis Heart and Vascular PC
St Louis, Missouri, 63136, United States
Methodist Physicians Clinic Heart Consultants
Omaha, Nebraska, 68114, United States
Palm Research Center Inc
Las Vegas, Nevada, 89128, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Advanced Heart Care LLC
Bridgewater, New Jersey, 08807, United States
Advanced Cardiology LLC
Cedar Knolls, New Jersey, 07927, United States
Overlook Hospital
Summit, New Jersey, 07901, United States
Virtua Health, Inc.
Voorhees Township, New Jersey, 08043, United States
Albany Medical College
Albany, New York, 12206, United States
Bassett Healthcare
Cooperstown, New York, 13326, United States
Long Island Cardiovascular Consultants
Lake Success, New York, 11042, United States
SJH Cardiology Associates
Liverpool, New York, 13088, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Northwell Health
New York, New York, 10011, United States
DiGiovanna Institute for Medical Education and Research
North Massapequa, New York, 11758, United States
Circuit Clinic
Orchard Park, New York, 14127, United States
Saratoga Clinical Research, LLC
Saratoga Springs, New York, 12866, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Montefiore Medical Center - Bronx
The Bronx, New York, 10467, United States
Duke Heart Center Clinical Research
Durham, North Carolina, 27710, United States
Cone Health
Greensboro, North Carolina, 27401, United States
Medication Management, LLC
Greensboro, North Carolina, 27405, United States
Vidant Cardiology
Greenville, North Carolina, 27834, United States
Novant Health Heart and Vascular Institute
Monroe, North Carolina, 28112, United States
Coastal Carolina Health Care PA
New Bern, North Carolina, 28562, United States
Pinehurst Medical Clinic, Inc
Pinehurst, North Carolina, 28374, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Sanford Cardiology
Sanford, North Carolina, 27330, United States
PMG Research of Piedmont HealthCare
Statesville, North Carolina, 28625, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University, Wexner Medical Center
Columbus, Ohio, 43210, United States
Premier Cardiovascular
Dayton, Ohio, 45414, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Heart House Research Foundation
Springfield, Ohio, 45504, United States
Saint Vincent Medical Center
Toledo, Ohio, 43608, United States
Central Oklahoma Early Detection Center
Edmond, Oklahoma, 73034, United States
Ascension St John Clinical Research Institute
Tulsa, Oklahoma, 74104, United States
Oklahoma State University Health Science Center
Tulsa, Oklahoma, 74127, United States
Lynn Institute of Tulsa
Tulsa, Oklahoma, 74135, United States
Central PA Physicians Group
Altoona, Pennsylvania, 16602, United States
Capital Area Research LLC
Camp Hill, Pennsylvania, 17011, United States
Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Doylestown Health Cardiology
Doylestown, Pennsylvania, 18901, United States
The Heart Group of Lancaster General Health
Lancaster, Pennsylvania, 17603, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Kent Hospital
Warwick, Rhode Island, 02886, United States
AnMed Health
Anderson, South Carolina, 29621, United States
PMG Research of Charleston
Charleston, South Carolina, 29407, United States
Columbia Heart
Columbia, South Carolina, 29203, United States
Upstate Cardiology
Greenville, South Carolina, 29607, United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701, United States
Diagnostic Cardiology Group
Chattanooga, Tennessee, 37404, United States
Stern Cardiovascular Foundation Inc
Germantown, Tennessee, 38138, United States
Parkway Cardiology Associates
Oak Ridge, Tennessee, 37830, United States
Seton Heart Institute
Austin, Texas, 78705, United States
Thyroid Endocrinology and Diabetes
Dallas, Texas, 75208, United States
Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Northwest Houston Cardiology
Houston, Texas, 77070, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
CardioVoyage
McKinney, Texas, 75071, United States
Texas Institute of Cardiology
McKinney, Texas, 75071, United States
Southern Endocrinology Associates PA
Mesquite, Texas, 75149, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
Consano Clinical Research
San Antonio, Texas, 78258, United States
San Antonio Endovascular and Heart Institute
San Antonio, Texas, 78258, United States
Village Medical Centers
The Woodlands, Texas, 77382, United States
Northwest Houston Heart Center
Tomball, Texas, 77375, United States
Tyler Cardiovascular Consultants
Tyler, Texas, 75701, United States
Cardiology Consultants of Danville, Inc
Danville, Virginia, 24541, United States
Virginia Heart
Falls Church, Virginia, 22042, United States
Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Carient Heart and Vascular
Manassas, Virginia, 20109, United States
Cardiovascular Associates of Virginia
Midlothian, Virginia, 23114, United States
Tidewater Physicians Multispecialty Group Clinical Research
Newport News, Virginia, 23606, United States
York Clinical Research LLC
Norfolk, Virginia, 23510, United States
Multicare Institute for Research and Innovation
Puyallup, Washington, 98372, United States
Washington University
Seattle, Washington, 98014, United States
Marshall Cardiology
Huntington, West Virginia, 25701, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Fraser River Endocrinology
Surrey, British Columbia, V3V 0C6, Canada
Cardio Metabolic Collaborative Clinic
Victoria, British Columbia, V8T 5G1, Canada
Discovery Clinical Services Ltd
Victoria, British Columbia, V8T 5G4, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
South Sherbrook Health Centre and Pharmacy
Winnipeg, Manitoba, R3C 2B3, Canada
Cardio 1
Winnipeg, Manitoba, R3L 1Z5, Canada
Brampton Clinical Trials
Brampton, Ontario, L6Z 4N5, Canada
Cambridge Cardiac Care Centre
Cambridge, Ontario, N1R 6V6, Canada
Saul Vizel Professional Medicine Corporation â€" Vizel Cardiac Research
Cambridge, Ontario, N1R 7R1, Canada
Cardiovasular Clinical Research Organization Limited
Greater Sudbury, Ontario, P3E 5M4, Canada
Curnew Medicine Professional Corporation
Hamilton, Ontario, L8L 0A9, Canada
Partners in Advanced Cardiac Evaluation
Newmarket, Ontario, L3Y 2P6, Canada
Oakville Cardiovascular Research Limited Partnership
Oakville, Ontario, L6K 3W7, Canada
Rhema Research Institute
Owen Sound, Ontario, N4K 3H1, Canada
Heart Health Institute Research Incorporated
Scarborough Village, Ontario, M1B 4Z8, Canada
Sewa Ram Singal Medicine Professional Corporation
Toronto, Ontario, M3N 2V6, Canada
Mohan Babapulle Medicine Professional Corporation
Waterloo, Ontario, N2T 0C1, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
McGill University Health Centre - Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Applied Medical Informatics Research Incorporated
Montreal, Quebec, H4A 3T2, Canada
CardioVasc HR Incorporated
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2019
First Posted
December 13, 2019
Study Start
December 6, 2019
Primary Completion
December 21, 2020
Study Completion
December 21, 2020
Last Updated
October 15, 2021
Record last verified: 2021-10