NCT04197453

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 752 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 40 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2019-12-06
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2019-12-13
• Last updated: 2021-10-15

Locations

164 sites across 2 countries: United States, Canada