Study identification

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
First published:
21/02/2024
Institution
Duke Clinical Research Institute Durham, USA

Contact details

Global Development Leader Amgen Inc. medinfo@amgen.com

Study contact
medinfo@amgen.com

Global Development Leader Amgen Inc.

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable