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ASCVDcvMOBIUSNCT04197453

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

An observational study of ASCVD, run by Amgen at 164 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 to 99 years
Conditions the study is for
ASCVD
How many people
752 participants
Where
164 sitesin 2 countries
Study dates
6 Dec 2019to 21 Dec 2020
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 10Show fewer
  • 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.

Trial locations and contacts

164 sites in 2 countries.

164 sites in 2 countries

United States143 sites

  • Albany Internal Medicine

    Albany, Georgia, 31707

  • Albany Medical College

    Albany, New York, 12206

  • Central PA Physicians Group

    Altoona, Pennsylvania, 16602

  • AnMed Health

    Anderson, South Carolina, 29621

  • Northwest Heart Clinical Research LLC

    Arlington Heights, Illinois, 60005

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Accel Research Sites

    Atlanta, Georgia, 30342

  • Seton Heart Institute

    Austin, Texas, 78705

  • McLaren Health

    Bay City, Michigan, 48708

  • Cardiovascular Research Foundation of Southern California

    Beverly Hills, California, 90210

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Grace Research LLC

    Bossier City, Louisiana, 71111

  • Bay Area Cardiology

    Brandon, Florida, 33511

  • Advanced Heart Care LLC

    Bridgewater, New Jersey, 08807

  • Capital Area Research LLC

    Camp Hill, Pennsylvania, 17011

  • Advanced Cardiology LLC

    Cedar Knolls, New Jersey, 07927

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • PMG Research of Charleston

    Charleston, South Carolina, 29407

  • Diagnostic Cardiology Group

    Chattanooga, Tennessee, 37404

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • University of Colorado Memorial Health System

    Colorado Springs, Colorado, 80909

  • Missouri Cardiovascular Specialists

    Columbia, Missouri, 65201

  • University of Missouri Health Care

    Columbia, Missouri, 65212

  • Columbia Heart

    Columbia, South Carolina, 29203

  • The Ohio State University, Wexner Medical Center

    Columbus, Ohio, 43210

  • Bassett Healthcare

    Cooperstown, New York, 13326

  • Thyroid Endocrinology and Diabetes

    Dallas, Texas, 75208

  • Southwest Family Medicine Associates

    Dallas, Texas, 75235

  • Cardiology Consultants of Danville, Inc

    Danville, Virginia, 24541

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52803

  • Premier Cardiovascular

    Dayton, Ohio, 45414

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Doylestown Health Cardiology

    Doylestown, Pennsylvania, 18901

  • Duke Heart Center Clinical Research

    Durham, North Carolina, 27710

  • Central Oklahoma Early Detection Center

    Edmond, Oklahoma, 73034

  • Evanston Premier Healthcare Research LLC

    Evanston, Illinois, 60201

  • Virginia Heart

    Falls Church, Virginia, 22042

  • First Georgia Physicians Group

    Fayetteville, Georgia, 30214

  • Holy Cross Hospital Inc

    Fort Lauderdale, Florida, 33308

  • The Cardiac and Vascular Institute Research

    Gainesville, Florida, 32605

  • Stern Cardiovascular Foundation Inc

    Germantown, Tennessee, 38138

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Cone Health

    Greensboro, North Carolina, 27401

  • Medication Management, LLC

    Greensboro, North Carolina, 27405

  • Vidant Cardiology

    Greenville, North Carolina, 27834

  • Upstate Cardiology

    Greenville, South Carolina, 29607

  • Heart Clinic of Hammond

    Hammond, Louisiana, 70403

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Northwest Houston Cardiology

    Houston, Texas, 77070

  • Marshall Cardiology

    Huntington, West Virginia, 25701

  • MedStar Health Research Institute Chesapeake Cardiovascular Associates

    Hyattsville, Maryland, 20782

  • Indiana University

    Indianapolis, Indiana, 46202

  • Saint Vincent Heart Center

    Indianapolis, Indiana, 46290

  • Jackson Heart

    Jackson, Mississippi, 39216

  • Baptist Heart Specialists

    Jacksonville Beach, Florida, 32250

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Long Island Cardiovascular Consultants

    Lake Success, New York, 11042

  • The Heart Group of Lancaster General Health

    Lancaster, Pennsylvania, 17603

  • Palm Research Center Inc

    Las Vegas, Nevada, 89128

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • Los Alamitos Cardiovascular

    Los Alamitos, California, 90720

  • Consortium of Attending Physicians for Research Investigations LLC

    Los Angeles, California, 90448

  • Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501

  • Carient Heart and Vascular

    Manassas, Virginia, 20109

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • CardioVoyage

    McKinney, Texas, 75071

  • Texas Institute of Cardiology

    McKinney, Texas, 75071

  • Southern Endocrinology Associates PA

    Mesquite, Texas, 75149

  • Cardiovascular Associates of Virginia

    Midlothian, Virginia, 23114

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • Clinical Trials of America Inc

    Monroe, Louisiana, 71201

  • Novant Health Heart and Vascular Institute

    Monroe, North Carolina, 28112

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Southwest Florida Research LLC

    Naples, Florida, 34102

  • Nanavati Critical Care Cardiology Clinic

    National City, California, 91950

  • Coastal Carolina Health Care PA

    New Bern, North Carolina, 28562

  • University Medical Center-New Orleans

    New Orleans, Louisiana, 70112

  • Ochsner Health Systems

    New Orleans, Louisiana, 70121

  • Northwell Health

    New York, New York, 10011

  • Tidewater Physicians Multispecialty Group Clinical Research

    Newport News, Virginia, 23606

  • York Clinical Research LLC

    Norfolk, Virginia, 23510

  • DiGiovanna Institute for Medical Education and Research

    North Massapequa, New York, 11758

  • Parkway Cardiology Associates

    Oak Ridge, Tennessee, 37830

  • Ocala Cardiovascular Research

    Ocala, Florida, 34474

  • Permian Research Foundation

    Odessa, Texas, 79761

  • Methodist Physicians Clinic Heart Consultants

    Omaha, Nebraska, 68114

  • Circuit Clinic

    Orchard Park, New York, 14127

  • Midwest Heart and Vascular Specialists

    Overland Park, Kansas, 66211

  • Premier Medical Group

    Owensboro, Kentucky, 42303

  • Palm Harbor Medical Associates

    Palm Harbor, Florida, 34684

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Cardiology Consultants

    Pensacola, Florida, 32501

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Pinehurst Medical Clinic, Inc

    Pinehurst, North Carolina, 28374

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Multicare Institute for Research and Innovation

    Puyallup, Washington, 98372

  • WakeMed

    Raleigh, North Carolina, 27610

  • Rancho Cucamonga Clinical Trials

    Rancho Cucamonga, California, 91730

  • Eisenhower Desert Cardiology Center

    Rancho Mirage, California, 92270

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • Reid Physician Associates

    Richmond, Indiana, 47374

  • TidalHealth Peninsula Regional, Inc

    Salisbury, Maryland, 21804

  • Consano Clinical Research

    San Antonio, Texas, 78258

  • San Antonio Endovascular and Heart Institute

    San Antonio, Texas, 78258

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Sanford Cardiology

    Sanford, North Carolina, 27330

  • Saratoga Clinical Research, LLC

    Saratoga Springs, New York, 12866

  • Washington University

    Seattle, Washington, 98014

  • Willis Knighton Cardiology

    Shreveport, Louisiana, 71103

  • Grace Research LLC

    Shreveport, Louisiana, 71105

  • Louisiana Heart Center

    Slidell, Louisiana, 70458

  • Prairie Cardiovascular Consultants

    Springfield, Illinois, 62701

  • Cox Medical Centers

    Springfield, Missouri, 65807

  • Heart House Research Foundation

    Springfield, Ohio, 45504

  • Washington University

    St Louis, Missouri, 63110

  • Saint Louis Heart and Vascular PC

    St Louis, Missouri, 63136

  • Cardiology Associates of Fairfield County, PC

    Stamford, Connecticut, 06905

  • PMG Research of Piedmont HealthCare

    Statesville, North Carolina, 28625

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Overlook Hospital

    Summit, New Jersey, 07901

  • Genesis Clinical Research Inc

    Tampa, Florida, 33614

  • Montefiore Medical Center - Bronx

    The Bronx, New York, 10467

  • Village Medical Centers

    The Woodlands, Texas, 77382

  • Millennium Clinical Trials

    Thousand Oaks, California, 91360

  • Saint Vincent Medical Center

    Toledo, Ohio, 43608

  • Northwest Houston Heart Center

    Tomball, Texas, 77375

  • Interventional Cardiac Consultants

    Trinity, Florida, 34655

  • Old Pueblo Cardiology

    Tucson, Arizona, 85712

  • Ascension St John Clinical Research Institute

    Tulsa, Oklahoma, 74104

  • Oklahoma State University Health Science Center

    Tulsa, Oklahoma, 74127

  • Lynn Institute of Tulsa

    Tulsa, Oklahoma, 74135

  • Tyler Cardiovascular Consultants

    Tyler, Texas, 75701

  • Central Coast Cardiovascular

    Ventura, California, 93003

  • Virtua Health, Inc.

    Voorhees Township, New Jersey, 08043

  • Kent Hospital

    Warwick, Rhode Island, 02886

  • MercyOne Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Canada21 sites

  • Brampton Clinical Trials

    Brampton, Ontario, L6Z 4N5

  • Cambridge Cardiac Care Centre

    Cambridge, Ontario, N1R 6V6

  • Saul Vizel Professional Medicine Corporation â€" Vizel Cardiac Research

    Cambridge, Ontario, N1R 7R1

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Cardiovasular Clinical Research Organization Limited

    Greater Sudbury, Ontario, P3E 5M4

  • Curnew Medicine Professional Corporation

    Hamilton, Ontario, L8L 0A9

  • McGill University Health Centre - Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Applied Medical Informatics Research Incorporated

    Montreal, Quebec, H4A 3T2

  • Partners in Advanced Cardiac Evaluation

    Newmarket, Ontario, L3Y 2P6

  • Oakville Cardiovascular Research Limited Partnership

    Oakville, Ontario, L6K 3W7

  • Rhema Research Institute

    Owen Sound, Ontario, N4K 3H1

  • CardioVasc HR Incorporated

    Saint-Jean-sur-Richelieu, Quebec, J3A 1J2

  • Heart Health Institute Research Incorporated

    Scarborough Village, Ontario, M1B 4Z8

  • Fraser River Endocrinology

    Surrey, British Columbia, V3V 0C6

  • Sewa Ram Singal Medicine Professional Corporation

    Toronto, Ontario, M3N 2V6

  • Cardio Metabolic Collaborative Clinic

    Victoria, British Columbia, V8T 5G1

  • Discovery Clinical Services Ltd

    Victoria, British Columbia, V8T 5G4

  • Mohan Babapulle Medicine Professional Corporation

    Waterloo, Ontario, N2T 0C1

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

  • South Sherbrook Health Centre and Pharmacy

    Winnipeg, Manitoba, R3C 2B3

  • Cardio 1

    Winnipeg, Manitoba, R3L 1Z5

Other trials in Canada

About this study

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.

Read the 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.

Conditions
ASCVD
Keywords
Lipids, Lipid-lowering therapy, Coronary heart disease, Peripheral arterial disease, Proprotein convertase subtilisin/kexin type 9 inhibition, Effectiveness
Medical subject headings
Coronary Disease, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04197453
Study groupRoleWhat they receive
Consented ArmSubjects 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) armSubjects 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

Secondary outcomes (10)

  1. Incident event rate for all-cause mortality

    Number of all-cause deaths divided by the person-time at risk

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  2. Incident event rate for non-fatal MI

    Number of incident non-fatal MI events divided by the person-time at risk

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  3. Incident event rate for non-fatal IS

    Number incident non-fatal IS events divided by the person-time at risk

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  4. Incident rate of coronary or peripheral or carotid revascularication procedures

    Number of incident coronary or peripherial or carotid revascularization procedures

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  5. 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).

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  6. Incident event rate for cardiovascular death

    Number of cardiovascular deaths divided by the person-time at risk

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  7. Incident event rate for transient ischemic attack (TIA)

    Number of incident TIA events divided by the person-time at risk

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  8. Incident event rate for unstable angina (UA)

    Number of incident UA events divided by the person-time at risk

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  9. 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

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

  10. 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.

    Measured: Through study completion, a minimum of 4.5 years and maximum of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start6 Dec 2019
  3. Primary completion21 Dec 2020
  4. Study completion21 Dec 2020

Why it stopped: Sponsor decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
752 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04197453
Sponsor's protocol ID
20180059
Acronym
cvMOBIUS
Status last verified
Oct 2021
First submitted
5 Dec 2019
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of ASCVD, run by Amgen at 164 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident event rate for the composite of all-cause mortality, non-fatal myocardial infarction (MI), and non-fatal ischemic stroke (IS). (time frame: Through study completion, a minimum of 4.5 years and maximum of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04197453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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