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Terminated/Withdrawn
Sponsor ID
20180059

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

Sponsor ID
20180059
Clinicaltrials.gov ID
NCT04197453
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 4
Product
Evolocumab
Type
Observational
Masking
N/A
Enrollment
752
Additional Study Details

Protocol Summary

Primary Outcome Measures

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 Outcome Measures

Incident event rate for all-cause mortality

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

Incident event rate for non-fatal MI

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

Incident event rate for non-fatal IS

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

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

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

Incident event rate for cardiovascular death

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

Incident event rate for transient ischemic attack (TIA)

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

Incident event rate for unstable angina (UA)

Timeframe: 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

Timeframe: 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

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

Locations

Location
Status
Contact Us
Location
CardioVoyage
Mckinney, TX, United States, 75071
Status
Completed
Location
Long Island Cardiovascular Consultants
Lake Success, NY, United States, 11042
Status
Completed
Location
Saul Vizel Professional Medicine Corporation – Vizel Cardiac Research
Cambridge, ON, Canada, N1R 7R1
Status
Completed
Location
Ecogene-21
Chicoutimi, QC, Canada, G7H 7K9
Status
Completed
Location
Discovery Clinical Services Ltd
Victoria, BC, Canada, V8T 5G4
Status
Completed
Location
Doylestown Health Cardiology
Doylestown, PA, United States, 18901
Status
Completed
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Study Info
Age
40 - 99 Years
Condition
  • Cardiovascular Disease
    • Sex
    All
    Trial Dates
    Dec 2019 - Dec 2020
    Inclusion and Exclusion 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.