The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (20180059) (cvMOBIUS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/36927
• EU PAS number:
  EUPAS32995
• Study ID:
  36927
• Official title and acronym:
  The Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 Inhibitors (20180059) (cvMOBIUS)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study description:
  The purpose of this registry to evaluate the effectiveness of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors 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 LTT 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Duke Clinical Research Institute (DCRI)

Duke Clinical Research Institute Durham, USA

Study timelines

Date when funding contract was signed

Planned: 09/07/2018

Actual: 28/01/2019

Study start date

Planned: 13/12/2019

Actual: 06/12/2019

Data analysis start date

Planned: 30/10/2026

Date of final study report

Planned: 05/03/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20180059_ Public Redacted Protocol Amend 2 English

Updated protocol

01.02.06 Public Redacted Protocol Ver 1.0 2019-12-06 English

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable