PC-SCA-9: Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01109706
• Collaborator: (none)
• Enrollment: 175
• Locations: 2
• Actual Duration (Months): 53
• Patients Per Site: 87.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Other: biological parameters dosage

Study Design

• Study Type: Observational
• Actual Enrollment: 175 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.
• Actual Study Start Date: Feb 13, 2011
• Actual Primary Completion Date: Sep 24, 2013
• Actual Study Completion Date: Jul 16, 2015

Arms and Interventions

Arm	Intervention/Treatment
patient treated by statines	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.
patient without normolipidemic treatment	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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)

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes University hospital	Nantes		France	44000
2	Nantes University Hospital	Nantes		France	44093

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Bertrand Cariou, MD, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01109706
• Other Study ID Numbers: BRD/10/03-ZE
• First Posted: Apr 23, 2010
• Last Update Posted: Sep 20, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Nantes University Hospital: Acute coronary syndrome; PCSK9; cardiovascular safety
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

No Results Posted as of Sep 20, 2021