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.
Brief Title
The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
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.
Completion Date
Completion Date Type
Actual
Conditions
ASCVD
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.
* 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.
Inclusion 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.
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
* 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.
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
Gender
All
Gender Based
false
Keywords
Lipids
Lipid-lowering therapy
Coronary heart disease
Peripheral arterial disease
Proprotein convertase subtilisin/kexin type 9 inhibition
Effectiveness
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
40 Years
NCT Id
NCT04197453
Org Class
Industry
Org Full Name
Amgen
Org Study Id
20180059
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
Primary Outcomes
Outcome Description
Number of incident all-cause deaths, non-fatal MI, and non-fatal IS events (whichever occurs first) divided by the person-time at risk
Outcome Measure
Incident event rate for the composite of all-cause mortality, non-fatal myocardial infarction (MI), and non-fatal ischemic stroke (IS).
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Secondary Outcomes
Outcome Description
Number of all-cause deaths divided by the person-time at risk
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident event rate for all-cause mortality
Outcome Description
Number of incident non-fatal MI events divided by the person-time at risk
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident event rate for non-fatal MI
Outcome Description
Number incident non-fatal IS events divided by the person-time at risk
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident event rate for non-fatal IS
Outcome Description
Number of incident coronary or peripherial or carotid revascularization procedures
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident rate of coronary or peripheral or carotid revascularication procedures
Outcome Description
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).
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident event rate for major adverse limb events (MALE) including amputation
Outcome Description
Number of cardiovascular deaths divided by the person-time at risk
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident event rate for cardiovascular death
Outcome Description
Number of incident TIA events divided by the person-time at risk
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident event rate for transient ischemic attack (TIA)
Outcome Description
Number of incident UA events divided by the person-time at risk
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Incident event rate for unstable angina (UA)
Outcome Description
Describe patterns of lipid control and LLT's over time
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
Longitudinal patterns of lipid control, use of and persistence with lipid lowering therapies (LLT) including statins, ezetimibe, and PCSK9 inhibitors
Outcome Description
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.
Outcome Time Frame
Through study completion, a minimum of 4.5 years and maximum of 5 years
Outcome Measure
The strengths and limitations of data harvested directly from electronic health record (EHR) systems as compared with prospectively collected information
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
All subjects must have an LDL-C \>=70 mg/dL or have initiated a PCSK9 inhibitor in the 6 months prior to enrollment.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
40
Investigators
Investigator Type
Principal Investigator
Investigator Name
Leandro Slipczuk Bustamante
Investigator Email
lslipczukb@montefiore.org
Investigator Phone