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Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.

NCT01109706 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 175

Last updated 2021-09-20

No results posted yet for this study

Summary

PCSK9 (Proprotein convertase subtilisin kexin type 9) plays a key role in LDL-cholesterol (LDLC) metabolism by inhibiting LDL receptor (LDLR) at post-transcriptional level. PCSK9 loss of function mutations are associated to decreased LDLC levels and a cardiovascular protection. In this context, the development of pharmacological inhibitors of PCSK9, in association with statins treatment, represents a major therapeutic issue for LDLC modulation. It was previously shown that PCSK9 plasmatic concentration correlated with plasmatic LDLC, TG and glucose concentrations. However, no data are available on predictive value of PCSK9 plasmatic level concerning coronary disease severity.

The main objective of this study is to determine whether plasmatic PCSK9 concentration is linked to coronary damage severity in patients with acute coronary syndrome.

Conditions

  • Acute Coronary Syndrome

Interventions

OTHER

biological parameters dosage

200 patients will be enrolled in the study (n=100 patients under statin treatment, n=100 patients without statin). After checking inclusion and non-inclusion criteria and obtaining informed consent from the patients. The SYNTAX score will be calculated and will allow to determine coronary analysis will be done at J1 and J4 (glucose, HbA1C, lipids, ApoA1, ApoB, sterols, plasmatic bile acids, insulinemia, creatinin clearance, hepatic function panel, CRPus and PCSK9 level assessment). Then, a sub-group of 30 patients will have supplementary blood analysis at 1 and 6 months after their admission, during their usual follow-up.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Bertrand Cariou, MD · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-13
Primary Completion
2013-09-24
Completion
2015-07-16

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01109706 on ClinicalTrials.gov