Clinical Trials Register

Summary
EudraCT Number:	2015-001189-24
Sponsor's Protocol Code Number:	SOLEaDO
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:	2021-09-06
Trial results	View 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

2015-001189-24

A.3

Full title of the trial

Oral vs Intravenous Aspirin administration in patients with ST-elevation Myocardial Infarction undergoing primary PCI.

SOmministrazione oraLE vs enDOvenosa di aspirina in pazienti con infarto miocardico acuto trattati con angioplastica primaria

A.3.1

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

Oral vs Intravenous Aspirin administration in patients with Myocardial Infarction undergoing primary PCI

Confronto tra la somministrazione di aspirina per bocca e la somministrazione di aspirina per via endovenosa in pazienti con infarto miocardico acuto trattati con angioplastica primaria

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

SOLEaDO

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	FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO
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	Fondazione IRCCS Policlinico San Matteo di Pavia
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	Fondazione IRCCS Policlinico San Matteo di Pavia
B.5.2	Functional name of contact point	Dr. Marco Ferlini
B.5.3	Address:
B.5.3.1	Street Address	P.le Golgi 19
B.5.3.2	Town/ city	Pavia
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0382501598
B.5.5	Fax number	0382501279
B.5.6	E-mail	m.ferlini@smatteo.pv.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	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.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACETILSALICILATO DI LISINA
D.3.9.1	CAS number	62952-06-1
D.3.9.2	Current sponsor code	NA
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	150
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	FLECTADOL - 500 MG POLVERE E SOLVENTE PER SOLUZIONE INETTABILEPER USO IM E EV 1 FLACONCINO+1 FIALA SOLVENTE DA 2.5 ML
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI-AVENTIS 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.3.4	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	NA
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	300
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

Myocardial Infarction

Infarto miocardico acuto

E.1.1.1

Medical condition in easily understood language

Myocardial Infarction

Infarto miocardico acuto

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	10028597
E.1.2	Term	Myocardial infarction acute
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10000891
E.1.2	Term	Acute myocardial infarction
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the effects of iv vs oral aspirin administration on platelets reactivity in patients with ST-elevation myocardial infarction

Confrontare gli effetti della somministrazione ev vs orale di ASA sulla reattività piastrinica indotta dal farmaco stesso

E.2.2

Secondary objectives of the trial

To evalutate efficacy and safety of the two administration routes

Valutare le eventuali differenze sugli eventi clinici di sicurezza ed efficacia associati alle due vie di somministrazione

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

aquisition of informed consent; age > 18 years; chest pain lasting more than 20 min; diagnosis of ST-elevation myocardial infarction undergoing primary PCI.

• Aver dato il proprio consenso informato scritto
• Avere una età > 18 anni
• Dolore toracico da più di 20 minuti
• ECG con sopraslivellamento persistente del tratto ST in almeno due derivazioni contigue (sotto-ST in V1-V3 in caso di localizzazione posteriore) o Blocco di branca sinistra di presunta nuova insorgenza.

E.4

Principal exclusion criteria

known aspirin intolerance; active major bleeding, known moderate to severe hepatic impairment, or hematologic diseases, known previous intracranial haemorragic stroke, aspirin untake in previous 7 days; swallow inability; planned concomitant treatment with Gp IIb-IIIa inhibitors, pregnancy.

• nota allergia ad ASA;
• sanguinamenti attivi o diatesi emorragiche;
• stato di gravidanza
• malattie ematologiche note;
• severe malattie epatiche;
• stroke emorragico pregresso;
• trattamento con ASA nei 7 gg precedenti;
• impossibilità a deglutire;
• impossibilità a firmare lo specifico consenso informato;
• trattamento pianificato con inibitori dei Gp IIb/IIIa.

E.5 End points

E.5.1

Primary end point(s)

Patients rate with ARU > 550 U (A vs B Group)

Percentuale di pazienti con ARU > 550 U nel Gruppo A (ev) vs Gruppo B (os)

E.5.1.1

Timepoint(s) of evaluation of this end point

2 hours after drug administration

2 ore dopo la dose di carico di ASA

E.5.2

Secondary end point(s)

Patient rate with ARU>550U at the other time points ; ARU values at different time points; Inhibition of platelet aggregation in the first 10 patients enrolled ; In-hospital major cardiovascular events: death all cause, myocardial infarction ; Stent thrombosis; In-hospital bleeding (TIMI calssification); ST segmet resolution > 70%

Percentuale di pazienti con ARU>550U agli altri intervalli temporali nei due gruppi; Valori assoluti di ARU ai differenti intervalli temporali nei due gruppi; Valori di inibizione della aggregazione piastrinica, nei primi 10 pazienti arruolati; Eventi cardiovascolari maggiori intraospedalieri (morte tutte le cause, reinfarto); Stent trombosi (ARC classificazione); Sanguinamenti intraospedalieri (classificazione TIMI); Risoluzione del tratto ST > del 70%

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 4 and 12 hours after administration; 1, 4 and 12 hours after administration; baseline and 1 and 4 hours after drug admnistration; At the end of study; At the end of study; At the end of study; 90-120 min after administration

dopo 1 ora, 4 ore e 12 ore dalla somministrazione; dopo 1 ora, 4 ore e 12 ore dalla somministrazione; al basale e dopo 1 e 4 ore dalla somministrazione; A fine studio; A fine studio; A fine studio; a 90-120 min dalla sommistrazione

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)

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Stesso farmaco ad altro dosaggio, altra via di somministrazione

Same active ingredient at different dose and different administration route

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

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

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)

Not applicable

Non applicabile

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

2015-11-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-07-06

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

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