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

Acute Coronary Syndrome Clinical Trial

— PC-SCA-9  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109706
• Other study ID #: BRD/10/03-ZE
• Status: Completed
• Start date: February 13, 2011
• Est. completion date: July 16, 2015

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: July 16, 2015
• Est. primary completion date: September 24, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• more than 18 years old

• Acute coronary syndrome (ST+ or ST-)

• 2 groups of patients: with statin, and without statin treatment

Exclusion criteria:

• Patient who had cancer during the last 5 years or with cancer in progress

• Patient with severe infection in progress

• Hepatic failure (TP<50%)

• Severe kidney failure

• Patient unable to give his consent to the study

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Nantes University hospital	Nantes
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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