CTQJ230A12001 Lp(a) Prevalence Study Version 00
Research type
Research Study
Full title
Multi-center cross-sectional epidemiological study to characterize the prevalence and distribution of lipoprotein(a) levels among patients with established cardiovascular disease
IRAS ID
256301
Contact name
Dev Datta
Contact email
Sponsor organisation
Novartis Pharma AG
Clinicaltrials.gov Identifier
2018-003786-34, European Clinical Trials Database (EudraCT) number:
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
Research Summary
Lipoprotein a is recognised as an independent risk factor biomarker for Cardiovascular Disease. CTQJ230A12001 is an epidemiological study to characterize the prevalence of lipoprotein(a) (Lp(a)) and its distribution among patients with established cardiovascular disease. This study aims to improve the knowledge about the epidemiology of Lp(a) in patients with established cardiovascular disease (CVD). The population will consist of approximately 45,000 males and females worldwide with established CVD.Summary of Results
Study CTQJ230A12001 is the largest multi-center cross sectional epidemiological study conducted to date, including 48,363 subjects to evaluate the prevalence and the distribution of Lp(a) levels in a targeted population with established CVD (Cardiovascular Disease). It supported the prior observations from large-scale epidemiological studies in the general population of a skewed distribution shifted towards Lp(a) levels suggestive of low CVD (Cardiovascular Disease) risk (Lp(a)< 30 mg/dL). The proportion of subjects at high cardiovascular (CV) risk due to elevated Lp(a) ≥ 50 mg/dL was higher (28.8%) than in previous studies (20%-24%). The finding of higher Lp(a) levels in the Black or African American race compared to other races was also reproduced. The mean LDL-C (Low-density lipoprotein cholesterol) values of approximately 80 mg/dL are in line with the LDL-C (Low-density lipoprotein cholesterol) levels from baseline characteristics of subjects with established CVD (Cardiovascular Disease) enrolled in cardiovascular trials. The calculated corrected LDL-C (Low-density lipoprotein cholesterol) values in the main Lp(a) subgroups supported previous reports about the contribution of the
apo(a) bound LDL-C (Low-density lipoprotein cholesterol) to the total LDL-C ( Low-density lipoprotein cholesterol) levels. No safety findings of concern have been reported in this study. The median Lp(a) levels observed were as expected based on previous studies in a very large number of subjects with established CVD (Cardiovascular Disease). LDL-C (Low-density lipoprotein cholesterol) levels and distribution were also as expected in this population.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
19/WM/0056
Date of REC Opinion
21 Mar 2019
REC opinion
Further Information Favourable Opinion