Clinical Trials Register

Summary
EudraCT Number:	2014-002672-86
Sponsor's Protocol Code Number:	Altshock
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2014-10-23
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

2014-002672-86

A.3

Full title of the trial

PHASE II CLINICAL TRIAL FOR A STEPWISE PROGRESSION IN THE TREATMENT OF CARDIOGENIC SHOCK

STUDIO DI FASE II PER LA VALUTAZIONE DI UN APPROCCIO TERAPEUTICO MULTISTEP IN PAZIENTI CON SHOCK CARDIOGENO – AltShock

A.3.1

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

PHASE II CLINICAL TRIAL FOR A STEPWISE PROGRESSION IN THE TREATMENT OF CARDIOGENIC SHOCK

STUDIO DI FASE II PER LA VALUTAZIONE DI UN APPROCCIO TERAPEUTICO MULTISTEP IN PAZIENTI CON SHOCK CARDIOGENO – AltShock

A.3.2

Name or abbreviated title of the trial where available

AltShock

A.4.1

Sponsor's protocol code number

Altshock

A.5.4

Other Identifiers

Name:

Not Applicable

Number:

Not Applicable

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	AO OSPEDALE NIGUARDA CA' GRANDA
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	AO NIGUARDA CA' GRANDA
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	dipartimento cardiotoracovascolare UTIC
B.5.2	Functional name of contact point	Dr Fabrizio Oliva
B.5.3	Address:
B.5.3.1	Street Address	P.zza Ospedale Maggiore
B.5.3.2	Town/ city	Milan
B.5.3.3	Post code	20162
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390264442576
B.5.5	Fax number	00390264442818
B.5.6	E-mail	fabriziogiovanni.oliva@ospedaleniguarda.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.2.1.2	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	Adrenalina
D.3.2	Product code	Adrenalina
D.3.4	Pharmaceutical form	Solution for infusion
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	na
D.3.9.1	CAS number	51-43-4
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	EPINEPHRINE
D.3.9.4	EV Substance Code	SUB06568MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1mg/1ml
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Patients affected by cardiogenic shock

Pazienti affetti da shock cardiogeno

E.1.1.1

Medical condition in easily understood language

Patients affected by cardiogenic shock

Pazienti affetti da shock cardiogeno

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

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

survival at 60 days

Sopravvivenza a 60 giorni

E.2.2

Secondary objectives of the trial

duration of i.v. infusion with adrenaline
adrenaline maximum dose
time to weaning from beginning with pharmacological therapy and mechanical ventricular support
length of stay
medical staff support and nursing-care hours
Safety endpoints:
absence of major ventricular arrhythmias
bleeding (3 and 5 according to BARC score)

Obiettivi secondari di efficacia
durata della terapia con adrenalina
dose massima di adrenalinatempo al weaning dai supporti farmacologici e meccanici
durata ospedalizzazione
monte ore assistenza medica e infermieristica
Obiettivi di sicurezza
assenza di aritmie ventricolari maggiori.
sanguinamenti (tipo 3 e 5 secondo la classificazione BARC)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age ≥ 18, males and females
Eligible patients have to fit at least TWO of the following criteria/items:
• SBP < 100 mmHg or MAP < 60 mmHg, after fluid challenge (at least 1000 ml of a crystalloid solution or 500 ml of a colloidal solution with right atrial pressure > 4 mmHg) or with a CVP > 12 mmHg or WCP >14 mmHg.
• Mixed venous oxygen saturation < 60%
• Arterial lactates > 2
• Oliguria < 0.5 ml/Kg/h

pazienti di entrambi i sessi, di età superiore o uguale ai 18 anni con almeno due dei seguenti parametri: PAS < 100 mmHg o PAM < 60 mmHg nonostante adeguato riempimento volemico (almeno 1000 ml di cristalloidi o 500 ml di colloidi con pressione atriale destra>4 mmHg)o in presenza di segni di incrementata pressione venosa centrale (> 12 mmHg) o incremento della pressioni di occlusione capillare polmonare (>14 mmHg); sat. venosa mista < 60%; lattati arteriosi > 2; oliguria < 0.5 ml/Kg/h.

E.4

Principal exclusion criteria

Pregnant, lactating or subjects planning pregnancy during the course of the trial.
Participants involved in other clinical trial.
Ongoing major arrhythmias: VT or VF or AF, with ventricular rate > 160 bpm
inability to sign the informed consent
Low output state due to hypovolemia (right atrial pressure <4 mmHg)
Septic shock
Severe Aortic or mitral stenosis
Obstructive hypertrophic cardiomiopathy or constrictive pericarditis or severe congenital cardiomiopathy
Comorbidities with ominous prognosis (life expectancy < 1 year)
Overt infection, hepatic, renal or pulmonary dysfunction, altered neurological status without clear prognosis after an acute cardiac arrest or following cardiogenic shock
Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant‟s ability to participate in the trial.

inclusione in altra sperimentazione clinica; aritmie severe in corso: tachicardia ventricolare o fibrillazione atriale con risposta ventricolare > 160 bpm; impossibilità di firmare il consenso informato; sindrome da bassa portata secondaria ad ipovolemia (pressione atriale destra<4 mmHg); shock settico; stenosi aortica o mitralica severa; cardiomiopatia ipertrofica ostruttiva o pericardite costrittiva o cardiopatia congenita clinicamente significativa; gravi copatologie con aspettativa di vita < 1 anno; infezione attiva, severa disfunzione epatica, renale o polmonare o stato neurologico incerto dopo arresto cardiaco o dovuto allo shock cardiogeno; donne in gravidanza.

E.5 End points

E.5.1

Primary end point(s)

number of successes

sopravvivenza

E.5.1.1

Timepoint(s) of evaluation of this end point

60 days

60 gg

E.5.2

Secondary end point(s)

mean and median values will be calculated together with their 95% confidence intervals and with the more suitable dispersion measure (standard deviation or range)

Endpoint secondari di efficacia:
durata della terapia con adrenalina
dose massima di adrenalina
tempo al weaning dai supporti farmacologici e meccanici
durata ospedalizzazione
monte ore assistenza medica e infermieristica

Endpoint di sicurezza:
assenza di aritmie ventricolari maggiori
sanguinamenti (Tipo 3 e 5 secondo la classificazione BARC)

E.5.2.1

Timepoint(s) of evaluation of this end point

not applicable

non disponibile

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

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

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

Ultima visita dell'ultimo paziente

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 months

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)

NONE

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

2015-04-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-26

P. End of Trial
P.	End of Trial Status	Ongoing

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