Acute Coronary SyndromePC-SCA-9NCT01109706
Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.
An observational study of Acute Coronary Syndrome, run by Nantes University Hospital at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- biological parameters dosage
- How many people
- 175 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2011to 16 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of both sexes, 18 years old minimum, with an acute coronary syndrome, treated or not with statins, admitted to cardiological intensive care unit.
Who may be able to join
- more than 18 years old
- Acute coronary syndrome (ST+ or ST-)
- 2 groups of patients: with statin, and without statin treatment
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes University hospital
Nantes, 44000
Nantes University Hospital
Nantes, 44093
About this study
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
- Being tested
- biological parameters dosage
- Keywords
- Acute coronary syndrome, PCSK9, cardiovascular safety
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological parameters dosageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patient treated by statines | Not described Receives: Other: biological parameters dosage | |
| patient without normolipidemic treatment | Not described Receives: Other: biological parameters dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1, Day 2, Day 3, Day 4
Secondary outcomes (4)
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
Measured: Day 1, Day 2, Day 3, Day 4
association between PCSK9 and metabolic/inflammatory factors
Identification of metabolic and inflammatory factors (glycemia, insulinemia, HbA1C, CRPus…) associated to plasma PCSK9 concentration
Measured: Day 1, Day 2, Day 3, Day 4
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)
Measured: Day 1, Day 2, Day 3, Day 4
kinetic of PCSK9 after intensive care
Determination of PCSK9 kinetic variation at 1 and 6 months after intensive care, during their normal follow-up
Measured: Day 1, Day 2, Day 3, Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study start13 Feb 2011
- Primary completion24 Sep 2013
- Study completion16 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Cariou, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109706
- Sponsor's protocol ID
- BRD/10/03-ZE
- Acronym
- PC-SCA-9
- Status last verified
- Sep 2021
- First submitted
- 20 Apr 2010
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Plasma PCSK9 Concentration as a Biomarker in Acute Coronary Syndrome.
- ClinicalTrials.gov ID
- NCT01109706
- Acronym / sponsor ID
- PC-SCA-9 / BRD/10/03-ZE
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute coronary syndrome, PCSK9, cardiovascular safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 13 Feb 2011 (actual)
- Primary completion
- 24 Sep 2013 (actual)
- Study completion
- 16 Jul 2015 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient treated by statines | – | Other: biological parameters dosage |
| patient without normolipidemic treatment | – | Other: biological parameters dosage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of both sexes, 18 years old minimum, with an acute coronary syndrome, treated or not with statins, admitted to cardiological intensive care unit.
Key inclusion criteria (3 listed)
- more than 18 years old
- Acute coronary syndrome (ST+ or ST-)
- 2 groups of patients: with statin, and without statin treatment
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological parameters dosage200 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. | Other | patient treated by statines, patient without normolipidemic treatment |
Primary outcome
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).
4 secondary outcomes
Correlation between PCSK9 and morbidity/mortality
Time frame: Day 1, Day 2, Day 3, Day 4
association between PCSK9 and metabolic/inflammatory factors
Time frame: Day 1, Day 2, Day 3, Day 4
kinetic of PCSK9 for statin-treated patients
Time frame: Day 1, Day 2, Day 3, Day 4
kinetic of PCSK9 after intensive care
Time frame: Day 1, Day 2, Day 3, Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Cariou, MD principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Syntax score (for evaluate coronary damages) and plasmatic concentration of PCSK9 (time frame: Day 1, Day 2, Day 3, Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2021.