Clinical Trials Register

Summary
EudraCT Number:	2010-024547-32
Sponsor's Protocol Code Number:	RBHP 2010 AZARNOUSCH
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-02-04
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2010-024547-32

A.3

Full title of the trial

Effets potentiels d’une supplémentation en oméga 3 sur la membrane des cardiomyocytes de patients atteints d’athérosclérose coronaire ?

A.3.2

Name or abbreviated title of the trial where available

CORONOMEGA3

A.4.1

Sponsor's protocol code number

RBHP 2010 AZARNOUSCH

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CHU Clermont-Ferrand
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	OMACOR
D.2.1.1.2	Name of the Marketing Authorisation holder	PRONOVA BIOPHARMA NORGE AS
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	0
D.3.9.3	Other descriptive name	OMEGA-3 ACID ETHYL ESTERS
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

patients avec indication de chirurgie de revascularisation coronaire

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Montrer une augmentation du taux d’acides gras polyinsaturés des membranes des cellules cardiaques dans le groupe de randomisation supplémenté.

E.2.2

Secondary objectives of the trial

- Montrer l’existence d’une modification membranaire des cardiomyocytes atriales chez les patients atteints d’athérosclérose coronaire bénéficiant d’une supplémentation péri-opératoire en oméga 3 pouvant expliquer la diminution de la fréquence de trouble du rythme postopératoire (fibrillation atriale)
- Montrer une diminution du syndrome inflammatoire

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Hommes de plus de 50 ans
Surcharge pondérale avec IMC > 25 et <40 (relever du périmètre abdominale)
Patients ayant donné leur consentement, bénéficiaire d’un régime de Sécurité Sociale
Chirurgie cardiaque programmée avec sternotomie et circulation extracorporelle de revascularisation myocardique, associée ou non à un remplacement valvulaire aortique biologique ou mécanique.

E.4

Principal exclusion criteria

- Liés à la chirurgie
Chirurgie en urgence,
Abord par thoracotomie,
Tout geste de chirurgie cardiaque autre que la revascularisation coronaire sous CEC +/- remplacement vasculaire aortique
Greffe cardiaque,
Dissection aortique,
Chirurgie redux

- Liés au patient :
Refus du protocole
Hypertriglycéridémie sous traitement (>2.25mmol/L)
Traitement par oméga 3 antérieur à l’étude
Traitement par fibrates
Patients majeurs protégés
Pathologie psychiatrique préexistante dont les états d’addiction connus
Incapacité physique ou intellectuelle
Pathologies préexistantes telles que insuffisance respiratoire évoluée (VEMS ou CV  50% de la théorique)
Insuffisance cardiaque (fraction d’éjection inférieure à 40% ou HTAP  50 mmHg de moyenne) ; contre-pulsion aortique ; état de choc cardiogénique préopératoire ;
Insuffisance rénale chronique ou aiguë préopératoire sévère avec une clairance de la créatinine inférieure à 40 mL/min, selon la formule de Cockroft et Gault
Hypersensibilité connue à l’un des médicaments de l’étude ou du protocole
Chirurgie en urgence
Infection en cours
Diabète
Dyslipidémie familiale
Ethylisme chronique (OMS :>28 verres de vin par semaine ou équivalent)
Antécédent d’intervention cardiaque ou thoracique avec ouverture péricardique
Insuffisance hépatique sévère et pathologie hépatique chronique grave
Présence d’arythmie complète par fibrillation atrial ou de flutter, en préopératoire, de manière chronique ou paroxystique.
Traitement par des anti-arythmiques de classe I ou III dans les trois mois précédents
Bloc atrio-ventriculaire
Présence du pacemaker temporaire au permanent préopératoire
Néoplasie évolutive
Patients sous corticoïde au long cours et porteurs de maladies inflammatoires
Patients sous AVK ou troubles connus de l’hémostase
Patients sous clopidogrel (Plavix ®), non stoppé depuis 5 jours en pré opératoire

E.5 End points

E.5.1

Primary end point(s)

Composition en acides gras polyinsaturés des membranes des cellules cardiaques (mesurer par chromatographie en phase gazeuse) à J 0.
- fluidité membranaire des cardiomyocytes
- taux plasmatiques d’acides gras polyinsaturés
- taux IL-6 et CRP
- rythme cardiaque post-opératoire.
- Durée de séjour en réanimation
- Durée de séjour post-opératoire total
- Morbi-mortalité

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Biologie moléculaire

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	No
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	30

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-02-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-03-17

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-03-15

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