Clinical trial NCT04197453: The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
Official title: The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: ASCVD
Keywords: Lipids
Lipid-lowering therapy
Coronary heart disease
Peripheral arterial disease
Proprotein convertase subtilisin/kexin type 9 inhibition
Effectiveness
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2019-12-13
Enrollment: 752
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

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