The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (cvMOBIUS)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 752
- 试验地点
- 162
- 主要终点
- Incident event rate for the composite of all-cause mortality, non-fatal myocardial infarction (MI), and non-fatal ischemic stroke (IS).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incident event rate for the composite of all-cause mortality, non-fatal myocardial infarction (MI), and non-fatal ischemic stroke (IS).
时间窗: 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
次要结局
- Incident event rate for all-cause mortality(Through study completion, a minimum of 4.5 years and maximum of 5 years)
- Incident event rate for non-fatal IS(Through study completion, a minimum of 4.5 years and maximum of 5 years)
- Incident event rate for transient ischemic attack (TIA)(Through study completion, a minimum of 4.5 years and maximum of 5 years)
- Incident event rate for cardiovascular death(Through study completion, a minimum of 4.5 years and maximum of 5 years)
- Incident event rate for non-fatal MI(Through study completion, a minimum of 4.5 years and maximum of 5 years)
- Incident rate of coronary or peripheral or carotid revascularication procedures(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(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(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(Through study completion, a minimum of 4.5 years and maximum of 5 years)
- Incident event rate for unstable angina (UA)(Through study completion, a minimum of 4.5 years and maximum of 5 years)