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

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01109706
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-20
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Study Start: 2011-02-13
• Primary Completion: 2013-09-24
• Study Completion: 2015-07-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9	Day 1, Day 2, Day 3, Day 4	Assessing the correlation between plasma concentration of PCSK9 and coronary damage severity in patients with acute coronary syndrome. Coronary lesions will be measured using the SYNTAX score (J0: admission day), and PCSK9 concentration will be evaluated using blood analysis (J0 (admission), J1, J2, J3 \& J4).

Secondary Outcome Measures

Name	Time	Method
association between PCSK9 and metabolic/inflammatory factors	Day 1, Day 2, Day 3, Day 4	Identification of metabolic and inflammatory factors (glycemia, insulinemia, HbA1C, CRPus...) associated to plasma PCSK9 concentration
kinetic of PCSK9 for statin-treated patients	Day 1, Day 2, Day 3, Day 4	Measurement of PCSK9 kinetic variation during ACS acute phase in patients treated with artovastatin 80 mg/day (J1, J2, J3, and J4)
Correlation between PCSK9 and morbidity/mortality	Day 1, Day 2, Day 3, Day 4	Assessing the correlation between plasma PCSK9 (J1, J2, J3, J4) concentration and one-year morbidity/mortality of patients with acute coronary syndrome
kinetic of PCSK9 after intensive care	Day 1, Day 2, Day 3, Day 4	Determination of PCSK9 kinetic variation at 1 and 6 months after intensive care, during their normal follow-up

Trial Locations

Locations (2)

Nantes University hospital; 🇫🇷 Nantes, France

Nantes University Hospital; 🇫🇷 Nantes, France