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NCT Number: NCT01109706

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biological parameters dosage

Other

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.

Primary outcomes

  1. Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9

    Time frame: 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 outcomes

  1. Correlation between PCSK9 and morbidity/mortality

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: PC-SCA-9

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Apr 23, 2010
Registry last updated
Sep 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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