Clinical Trials Register

Summary
EudraCT Number:	2017-001754-33
Sponsor's Protocol Code Number:	SDAT-IRC
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-09-27
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

2017-001754-33

A.3

Full title of the trial

Single versus Dual Antiplatelet Therapy in patients with Incomplete Revascularization after Coronary artery bypass graft surgery

Studio prospettico randomizzato per valutare l’effetto della doppia terapia antiaggregante piastrinica in pazienti sottoposti a bypass aortocoronarico con rivascolarizzazione miocardica incompleta

A.3.1

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

Single versus Dual Antiplatelet Therapy in patients with Incomplete Revascularization after Coronary artery bypass graft surgery

Studio prospettico randomizzato per valutare l’effetto della doppia terapia antiaggregante piastrinica in pazienti sottoposti a bypass aortocoronarico con rivascolarizzazione miocardica incompleta

A.3.2

Name or abbreviated title of the trial where available

SDAT-IRC Study

A.4.1

Sponsor's protocol code number

SDAT-IRC

A.5.4

Other Identifiers

Name:

SDAT-IRC

Number:

SDAT-IRC

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	UNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
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	Università Campus Bio-Medico di Roma
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Università Campus Bio-Medico di Roma
B.5.2	Functional name of contact point	Ufficio Sperimentazioni Cliniche
B.5.3	Address:
B.5.3.1	Street Address	Via Alvaro del Portillo 200
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00128
B.5.3.4	Country	Italy
B.5.4	Telephone number	06225418874
B.5.5	Fax number	000
B.5.6	E-mail	manuela.greco@unicampus.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	BRILIQUE - 90 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - BLISTER(PVC/PVDC/ALU) 60 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ASTRAZENECA AB
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.3.4	Pharmaceutical form	Film-coated 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	TICAGRELOR
D.3.9.2	Current sponsor code	120915
D.3.9.3	Other descriptive name	BRILIQUE
D.3.9.4	EV Substance Code	SUB30898
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	90
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	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	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	CARDIOASPIRINA
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 ACETILSALICILICO
D.3.9.1	CAS number	50-78-2
D.3.9.2	Current sponsor code	120915
D.3.9.3	Other descriptive name	ASPIRIN
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

in patients with Incomplete Revascularization after Coronary artery bypass graft surgery

valutare l'effetto della doppia terapia antiaggregante piastrinica in pazienti sottoposti a bypass aortocoronarico con rivascolarizzazione miocardica incompleta.

E.1.1.1

Medical condition in easily understood language

Incomplete Revascularization after Coronary artery bypass graft surgery

bypass aortocoronarico con rivascolarizzazione miocardica incompleta.

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	10032492
E.1.2	Term	Other specified acute and subacute form of 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

L’endpoint primario dello studio è la valutazione della mortalità per causa cardiaca, e verrà in maniera conclusiva a 5 anni dalla dimissione.

E.2.2

Secondary objectives of the trial

Gli endpoints secondari dello studio sono:
• valutazione della mortalità complessiva (cardiaca e non-cardiaca)
• valutazione degli eventi cardiaci e cerebrovascolari avversi maggiori (MACCEs): mortalità cardiaca, infarto miocardico, procedura di rivascolarizzazione su vaso già trattato (“repeated vessel revascularization”), ospedalizzazione per scompenso cardiaco, aritmie cardiache maggiori, stroke
• valutazione degli eventi emorragici maggiori (stroke emorragico o sanguinamento gastrointestinale)

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Other types of substudies
Specify title, date and version of each substudy with relative objectives: saranno previste sotto-analisi per i pazienti sottoposti a rivascolarizzazione miocardica totalmente arteriosa ("total arterial CABG") e pazienti operati senza l'ausilio della circolazione extra-corporea ("off-pump CABG")

Altre tipologie di sottostudi
specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: saranno previste sotto-analisi per i pazienti sottoposti a rivascolarizzazione miocardica totalmente arteriosa ("total arterial CABG") e pazienti operati senza l'ausilio della circolazione extra-corporea ("off-pump CABG")

E.3

Principal inclusion criteria

evaluate dual antiplatelet treatment after incomplete revascularization in CABG

Criteri di inclusione:
• pazienti sottoposti a bypass aortocoronarico e eventuali procedure associate (chirurgia valvolare aortica, chirurgia valvolare mitralica, chirurgia valvolare tricuspidalica, chirurgia dell’aorta ascendente), con o senza ausilio della circolazione extracorporea
• rivascolarizzazione miocardica incompleta, definita secondo i criteri anatomici (J Am Coll Cardiol 2013;62:1421–31, considerando la seguente definizione di “rivascolarizzazione completa”: all diseased arterial systems with vessel size = 1.5 mm (2.0-2.25 mm for PCI) with at least one significant stenosis = 50% receive a graft)

E.4

Principal exclusion criteria

• sindrome coronarica acuta entro 12 mesi dall’intervento chirurgico
• paziente in trattamento con doppia terapia antiaggregante piastrinica al ricovero ospedaliero
• completamento programmato di rivascolarizzazione miocardica mediante procedure percutanee (angioplastica coronarica) nei successivi 12 mesi
• pazienti con intolleranza o controindicazione a ticagrelor o Cardioaspirina, secondo scheda tecnica
• fibrillazione atriale pre-operatoria in trattamento con TAO (terapia anticoagulate orale, es. Coumadin) o NAO (nuovi anticoagulanti orali, es. Pradaxa)
• pazienti con alterazioni dello stato psichico che alterano la compliance al trattamento

E.5 End points

E.5.1

Primary end point(s)

cardiac mortality

mortalità per causa cardiaca

E.5.1.1

Timepoint(s) of evaluation of this end point

1-2-3-4-5 years

1-2-3-4-5 anni

E.5.2

Secondary end point(s)

• valutazione della mortalità complessiva (cardiaca e non-cardiaca)
• valutazione degli eventi cardiaci e cerebrovascolari avversi maggiori (MACCEs): mortalità cardiaca, infarto miocardico, procedura di rivascolarizzazione su vaso già trattato (“repeated vessel revascularization”), ospedalizzazione per scompenso cardiaco, aritmie cardiache maggiori, stroke
• valutazione degli eventi emorragici maggiori (stroke emorragico o sanguinamento gastrointestinale)

E.5.2.1

Timepoint(s) of evaluation of this end point

1-2-3-4-5 years

1-2-3-4-5 anni

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

....

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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

800

F.4.2

For a multinational trial

F.4.2.1

In the EEA

800

F.4.2.2

In the whole clinical trial

800

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)

not different from the expected normal treatment of that condition

non differisce dal normale trattamento

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

2018-09-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-10-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-10-07

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