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

ASCVD Clinical Trial

— cvMOBIUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04197453
• Other study ID #: 20180059
• Status: Terminated
• Start date: December 6, 2019
• Est. completion date: December 21, 2020

Study information

• Verified date: October 2021
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 752
• Est. completion date: December 21, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• ASCVD

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Duke Clinical Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   AmgenTrials clinical trials website