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Trial record 1 of 1 for:    04197453
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The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS) (cvMOBIUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04197453
Recruitment Status : Active, not recruiting
First Posted : December 13, 2019
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Amgen

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.

Condition or disease
ASCVD

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 752 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : March 23, 2027
Estimated Study Completion Date : March 23, 2027

Group/Cohort
Consented Arm
Subjects 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) arm
Subjects 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.



Primary Outcome Measures :
  1. 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 ]
    Number of incident all-cause deaths, non-fatal MI, and non-fatal IS events (whichever occurs first) divided by the person-time at risk


Secondary Outcome Measures :
  1. Incident event rate for all-cause mortality [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Number of all-cause deaths divided by the person-time at risk

  2. Incident event rate for non-fatal MI [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Number of incident non-fatal MI events divided by the person-time at risk

  3. Incident event rate for non-fatal IS [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Number incident non-fatal IS events divided by the person-time at risk

  4. Incident rate of coronary or peripheral or carotid revascularication procedures [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Number of incident coronary or peripherial or carotid revascularization procedures

  5. Incident event rate for major adverse limb events (MALE) including amputation [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    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).

  6. Incident event rate for cardiovascular death [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Number of cardiovascular deaths divided by the person-time at risk

  7. Incident event rate for transient ischemic attack (TIA) [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Number of incident TIA events divided by the person-time at risk

  8. Incident event rate for unstable angina (UA) [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Number of incident UA events divided by the person-time at risk

  9. Longitudinal patterns of lipid control, use of and persistence with lipid lowering therapies (LLT) including statins, ezetimibe, and PCSK9 inhibitors [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    Describe patterns of lipid control and LLT's over time

  10. The strengths and limitations of data harvested directly from electronic health record (EHR) systems as compared with prospectively collected information [ Time Frame: Through study completion, a minimum of 4.5 years and maximum of 5 years ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197453


Locations
Show Show 161 study locations
Sponsors and Collaborators
Amgen
Duke Clinical Research Institute
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04197453    
Other Study ID Numbers: 20180059
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Lipids
Lipid-lowering therapy
Coronary heart disease
Peripheral arterial disease
Proprotein convertase subtilisin/kexin type 9 inhibition
Effectiveness