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

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.

Study Overview

• Status: Terminated
• Conditions: ASCVD

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.

• Study Type: Observational
• Enrollment (Actual): 752

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Fraser River Endocrinology
    • Victoria, British Columbia, Canada, V8T 5G1
      • Cardio Metabolic Collaborative Clinic
    • Victoria, British Columbia, Canada, V8T 5G4
      • Discovery Clinical Services Ltd
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3C 0N2
      • Winnipeg Clinic
    • Winnipeg, Manitoba, Canada, R3C 2B3
      • South Sherbrook Health Centre and Pharmacy
    • Winnipeg, Manitoba, Canada, R3L 1Z5
      • Cardio 1
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
      • Brampton Clinical Trials
    • Cambridge, Ontario, Canada, N1R 6V6
      • Cambridge Cardiac Care Centre
    • Cambridge, Ontario, Canada, N1R 7R1
      • Saul Vizel Professional Medicine Corporation â€" Vizel Cardiac Research
    • Hamilton, Ontario, Canada, L8L 0A9
      • Curnew Medicine Professional Corporation
    • Newmarket, Ontario, Canada, L3Y 2P6
      • Partners in Advanced Cardiac Evaluation
    • Oakville, Ontario, Canada, L6K 3W7
      • Oakville Cardiovascular Research Limited Partnership
    • Owen Sound, Ontario, Canada, N4K 3H1
      • Rhema Research Institute
    • Scarborough, Ontario, Canada, M1B 4Z8
      • Heart Health Institute Research Incorporated
    • Sudbury, Ontario, Canada, P3E 5M4
      • Cardiovasular Clinical Research Organization Limited
    • Toronto, Ontario, Canada, M3N 2V6
      • Sewa Ram Singal Medicine Professional Corporation
    • Waterloo, Ontario, Canada, N2T 0C1
      • Mohan Babapulle Medicine Professional Corporation
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21
    • Montreal, Quebec, Canada, H3G 1A4
      • McGill University Health Centre - Montreal General Hospital
    • Montreal, Quebec, Canada, H4A 3T2
      • Applied Medical Informatics Research Incorporated
    • St Jean sur Richelieu, Quebec, Canada, J3A 1J2
      • CardioVasc HR Incorporated
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Mercy Gilbert Medical Center
    • Tucson, Arizona, United States, 85712
      • Old Pueblo Cardiology
  • California
    • Beverly Hills, California, United States, 90210
      • Cardiovascular Research Foundation of Southern California
    • Los Alamitos, California, United States, 90720
      • Los Alamitos Cardiovascular
    • Los Angeles, California, United States, 90448
      • Consortium of Attending Physicians for Research Investigations LLC
    • National City, California, United States, 91950
      • Nanavati Critical Care Cardiology Clinic
    • Rancho Cucamonga, California, United States, 91730
      • Rancho Cucamonga Clinical Trials
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Desert Cardiology Center
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
    • Thousand Oaks, California, United States, 91360
      • Millennium Clinical Trials
    • Ventura, California, United States, 93003
      • Central Coast Cardiovascular
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • University of Colorado Memorial Health System
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
    • Stamford, Connecticut, United States, 06905
      • Cardiology Associates of Fairfield County, PC
  • Florida
    • Brandon, Florida, United States, 33511
      • Bay Area Cardiology
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital Inc
    • Gainesville, Florida, United States, 32605
      • The Cardiac and Vascular Institute Research
    • Jacksonville Beach, Florida, United States, 32250
      • Baptist Heart Specialists
    • Naples, Florida, United States, 34102
      • Southwest Florida Research LLC
    • Ocala, Florida, United States, 34474
      • Ocala Cardiovascular Research
    • Palm Harbor, Florida, United States, 34684
      • Palm Harbor Medical Associates
    • Pensacola, Florida, United States, 32501
      • Cardiology Consultants
    • Tampa, Florida, United States, 33614
      • Genesis Clinical Research Inc
    • Trinity, Florida, United States, 34655
      • Interventional Cardiac Consultants
  • Georgia
    • Albany, Georgia, United States, 31707
      • Albany Internal Medicine
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
    • Atlanta, Georgia, United States, 30342
      • Accel Research Sites
    • Fayetteville, Georgia, United States, 30214
      • First Georgia Physicians Group
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Northwest Heart Clinical Research LLC
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr Hospital of Cook County
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare Research LLC
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
    • Springfield, Illinois, United States, 62701
      • Prairie Cardiovascular Consultants
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
    • Indianapolis, Indiana, United States, 46290
      • Saint Vincent Heart Center
    • Richmond, Indiana, United States, 47374
      • Reid Physician Associates
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
    • West Des Moines, Iowa, United States, 50266
      • MercyOne Iowa Heart Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center
    • Overland Park, Kansas, United States, 66211
      • Midwest Heart and Vascular Specialists
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Premier Medical Group
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Grace Research Llc
    • Hammond, Louisiana, United States, 70403
      • Heart Clinic of Hammond
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of America Inc
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center-New Orleans
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health Systems
    • Shreveport, Louisiana, United States, 71105
      • Grace Research Llc
    • Shreveport, Louisiana, United States, 71103
      • Willis Knighton Cardiology
    • Slidell, Louisiana, United States, 70458
      • Louisiana Heart Center
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute Chesapeake Cardiovascular Associates
    • Salisbury, Maryland, United States, 21804
      • TidalHealth Peninsula Regional, Inc
  • Michigan
    • Bay City, Michigan, United States, 48708
      • McLaren Health
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care
    • Columbia, Missouri, United States, 65201
      • Missouri Cardiovascular Specialists
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63136
      • Saint Louis Heart and Vascular PC
    • Springfield, Missouri, United States, 65807
      • Cox Medical Centers
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Physicians Clinic Heart Consultants
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Palm Research Center Inc
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Advanced Heart Care LLC
    • Cedar Knolls, New Jersey, United States, 07927
      • Advanced Cardiology LLC
    • Summit, New Jersey, United States, 07901
      • Overlook Hospital
    • Voorhees, New Jersey, United States, 08043
      • Virtua Health, Inc.
  • New York
    • Albany, New York, United States, 12206
      • Albany Medical College
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center - Bronx
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare
    • Lake Success, New York, United States, 11042
      • Long Island Cardiovascular Consultants
    • Liverpool, New York, United States, 13088
      • SJH Cardiology Associates
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10011
      • Northwell Health
    • North Massapequa, New York, United States, 11758
      • DiGiovanna Institute for Medical Education And Research
    • Orchard Park, New York, United States, 14127
      • Circuit Clinic
    • Saratoga Springs, New York, United States, 12866
      • Saratoga Clinical Research, LLC
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Heart Center Clinical Research
    • Greensboro, North Carolina, United States, 27405
      • Medication Management, LLC
    • Greensboro, North Carolina, United States, 27401
      • Cone Health
    • Greenville, North Carolina, United States, 27834
      • Vidant Cardiology
    • Monroe, North Carolina, United States, 28112
      • Novant Health Heart and Vascular Institute
    • New Bern, North Carolina, United States, 28562
      • Coastal Carolina Health Care PA
    • Pinehurst, North Carolina, United States, 28374
      • Pinehurst Medical Clinic, Inc
    • Raleigh, North Carolina, United States, 27610
      • WakeMed
    • Sanford, North Carolina, United States, 27330
      • Sanford Cardiology
    • Statesville, North Carolina, United States, 28625
      • PMG Research of Piedmont Healthcare
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • The Ohio State University, Wexner Medical Center
    • Dayton, Ohio, United States, 45414
      • Premier Cardiovascular
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Springfield, Ohio, United States, 45504
      • Heart House Research Foundation
    • Toledo, Ohio, United States, 43608
      • Saint Vincent Medical Center
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Central Oklahoma Early Detection Center
    • Tulsa, Oklahoma, United States, 74104
      • Ascension St John Clinical Research Institute
    • Tulsa, Oklahoma, United States, 74127
      • Oklahoma State University Health Science Center
    • Tulsa, Oklahoma, United States, 74135
      • Lynn Institute of Tulsa
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
      • Central PA Physicians Group
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research LLC
    • Chambersburg, Pennsylvania, United States, 17201
      • Chambersburg Hospital
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Health Cardiology
    • Lancaster, Pennsylvania, United States, 17603
      • The Heart Group of Lancaster General Health
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Kent Hospital
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health
    • Charleston, South Carolina, United States, 29407
      • PMG Research of Charleston
    • Columbia, South Carolina, United States, 29203
      • Columbia Heart
    • Greenville, South Carolina, United States, 29607
      • Upstate Cardiology
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Diagnostic Cardiology Group
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Foundation Inc
    • Oak Ridge, Tennessee, United States, 37830
      • Parkway Cardiology Associates
  • Texas
    • Austin, Texas, United States, 78705
      • Seton Heart Institute
    • Dallas, Texas, United States, 75235
      • Southwest Family Medicine Associates
    • Dallas, Texas, United States, 75208
      • Thyroid Endocrinology and Diabetes
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77070
      • Northwest Houston Cardiology
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates
    • McKinney, Texas, United States, 75071
      • CardioVoyage
    • McKinney, Texas, United States, 75071
      • Texas Institute of Cardiology
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates PA
    • Odessa, Texas, United States, 79761
      • Permian Research Foundation
    • San Antonio, Texas, United States, 78258
      • Consano Clinical Research
    • San Antonio, Texas, United States, 78258
      • San Antonio Endovascular and Heart Institute
    • The Woodlands, Texas, United States, 77382
      • Village Medical Centers
    • Tomball, Texas, United States, 77375
      • Northwest Houston Heart Center
    • Tyler, Texas, United States, 75701
      • Tyler Cardiovascular Consultants
  • Virginia
    • Danville, Virginia, United States, 24541
      • Cardiology Consultants of Danville, Inc
    • Falls Church, Virginia, United States, 22042
      • Virginia Heart
    • Lynchburg, Virginia, United States, 24501
      • Stroobants Cardiovascular Center
    • Manassas, Virginia, United States, 20109
      • Carient Heart and Vascular
    • Midlothian, Virginia, United States, 23114
      • Cardiovascular Associates of Virginia
    • Newport News, Virginia, United States, 23606
      • Tidewater Physicians Multispecialty Group Clinical Research
    • Norfolk, Virginia, United States, 23510
      • York Clinical Research LLC
  • Washington
    • Puyallup, Washington, United States, 98372
      • Multicare Institute for Research and Innovation
    • Seattle, Washington, United States, 98014
      • Washington University
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall Cardiology
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident event rate for all-cause mortality	Number of all-cause deaths divided by the person-time at risk	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	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	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	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).	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	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	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	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	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.	Through study completion, a minimum of 4.5 years and maximum of 5 years

Collaborators and Investigators

• Sponsor: Amgen
• Collaborators: Duke Clinical Research Institute

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2019
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 8, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Coronary heart disease; Lipids; Lipid-lowering therapy; Effectiveness; Proprotein convertase subtilisin/kexin type 9 inhibition
• Other Study ID Numbers: 20180059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No