Clinical Trials Register

Summary
EudraCT Number:	2016-004157-33
Sponsor's Protocol Code Number:	CCM525
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2021-06-08
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-004157-33

A.3

Full title of the trial

Effect of the administration of 75 mg of acetylsalicylic acid + 200mg of triglycerides of n-3 series fatty acids (omega 3 + ASA) on the biosynthesis of platelet thromboxane A2 in patients with cardiovascular disease.

Effetto della somministrazione di 75 mg di acido acetilsalicilico + 200mg di trigliceridi di acidi grassi della serie n-3 (omega 3+ASA) sulla biosintesi di trombossano A2 piastrinico in pazienti con malattia cardiovascolare.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

To evaluate the effect and tollerability of 2 different formulations of acetylsalicylic acid of which one associated with 200mg of triglycerides of n-3 series fatty acids (omega 3 + ASA)

Valutare l'effeto e la tollerabilit¿ del trattamento con 2 formulazioni diverse di acido acetilsalicilico di cui una ¿ associata a 200 mg di trigliceridi di acidi grassi -3

A.3.2

Name or abbreviated title of the trial where available

NASA (n-3 and ASA in patients with Stable Angina)

A.4.1

Sponsor's protocol code number

CCM525

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CENTRO CARDIOLOGICO SPA FONDAZIONE MONZINO
B.1.3.4	Country	Italy
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	IBSA
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ISTITUTO EUROPEO ONCOLOGIA
B.5.2	Functional name of contact point	UFFICIO STUDI CLINICI E ATTIV. REGO
B.5.3	Address:
B.5.3.1	Street Address	VIA ADAMELLO 16
B.5.3.2	Town/ city	MILANO
B.5.3.3	Post code	20141
B.5.3.4	Country	Italy
B.5.4	Telephone number	0257489848
B.5.5	Fax number	0257489781
B.5.6	E-mail	ufficio.studiclinici@ieo.it

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	CARDIORAL - 75 MG CAPSULE MOLLI 30 CAPSULE IN BLISTER PCTFE/AL
D.2.1.1.2	Name of the Marketing Authorisation holder	IBSA FARMACEUTICI ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.1	Product name	CARDIORAL
D.3.4	Pharmaceutical form	Capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACIDO SALICILICO
D.3.9.2	Current sponsor code	CARDIORAL
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	No
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	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	CARDIOASPIRIN - 100 MG COMPRESSE GASTRORESISTENTI30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	BAYER S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.1	Product name	CARDIOASPIRIN
D.3.4	Pharmaceutical form	Gastro-resistant tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACIDO SALICILICO
D.3.9.2	Current sponsor code	CARDIOASPIRIN
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	No
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	No
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

Chronic ischemic cardiopathy

Cardiopatia ischemica cronica

E.1.1.1

Medical condition in easily understood language

Chronic ischemic cardiopathy

Cardiopatia ischemica cronica

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10032060
E.1.2	Term	Other forms of chronic ischemic heart disease
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate if treatment with of 75 mg of acetylsalicylic acid + 200 mg of n-3 fatty acids (omega 3 + ASA) is able to inhibit platelet COX-1 in vivo, in a similar way as the treatment with 100 mg acetylsalicylic acid (non inferiority limit of 6.7%).

Valutare se un trattamento con 75 mg ASA + 200 mg omega-3 ¿ in grado di inibire la COX-1 piastrinica in vivo con un¿efficacia (effetto antipiastrinico) paragonabile a quella con ASA 100mg (limite di non inferiorit¿ del 6.7%)

E.2.2

Secondary objectives of the trial

Evaluation of tolerability (pro-haemorragic effect and "coronary instability" of treatments. Evaluation of the efficacy (anti-platelet effect) on platelet COX 1 inhibition ex vivo

Valutare la tollerabilit¿ (effetto pro-emorragico e possibilit¿ di comparsa di ¿instabilit¿ coronarica¿) dei trattamenti. Valutare l¿efficacia (effetto antipiastrinico) dei trattamenti nell¿inibire la COX-1 piastrinica ex vivo.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients with stable coronary heart disease, aged between 18 and 80 years, already treatrd with ASA 100 mg for at least one month.

Pazienti con coronaropatia stabile, di età compresa tra i 18 e gli 80 anni, già in trattamento con ASA 100 mg da almeno 1 mese.

E.4

Principal exclusion criteria

The exclusion criteria are: a percutaneous angioplasty or acute coronary syndrome in the month prior to randomization; treatment with inhibitors of glycoprotein IIb / IIIa or thrombolytics agents in the month prior to randomization; concomitant treatment with products containing fatty acids of the n-3 series; concomitant treatment with ibuprofen, naproxen, or warfarin; thrombocytopenia (platelet count =100x103 cells / mm3); anemia (hemoglobin =10 g / dl); renal impairment (creatinine 2.5 mg / dl).

I criteri di esclusione sono: una angioplastica percutanea o una sindrome coronarica acuta nel mese precedente la randomizzazione; trattamento con inibitori della glicoproteina IIb / IIIa o agenti trombolitici nel mese precedente la randomizzazione; trattamento concomitante con prodotti contenenti acidi grassi della serie n-3; trattamento concomitante con ibuprofene, naprossene, o warfarin ; trombocitopenia (numero di piastrine =100x103 cellule/mm3); anemia (emoglobina =10 g/dl ); insufficienza renale (creatinina 2,5 mg/dl) .

E.5 End points

E.5.1

Primary end point(s)

Evaluate the efficacy (antiplatelet effect) of Cardioral (75 mg ASA + 200 mg omega-3) in inhibiting platelet COX-1

Valutare l’efficacia (effetto antipiastrinico) di Cardioral (75 mg ASA + 200 mg omega-3) nell’inibire la COX-1 piastrinica

E.5.1.1

Timepoint(s) of evaluation of this end point

before treatment and afterwards on days 1, 7, 36, 60 e 90 of treatment

prima dell'inizio del trattamento e poi nei giorni 1, 7, 36, 60 e 90 di trattamento

E.5.2

Secondary end point(s)

monitoring for haemorragic effects or coronary instability

rilevazione di eventuali eventi emorragici o di instabilit¿ coronarica

E.5.2.1

Timepoint(s) of evaluation of this end point

during the whole duration of the study and in particular on days 1, 7, 36, 60 e 90 of treatment

per tutta la durata dello studio ed in particolare nei giorni 1, 7, 36, 60 e 90 di trattamento

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

E.6.4

Safety

Yes

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.5.1

Number of sites anticipated in the EEA

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

LVLS

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

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

patintes will receive the usual treatment with salicilic acid

i pazienti riprenderanno la loro terapia abituale con ac. salicilico

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

2021-05-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-29

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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