Clinical Trials Register

Summary
EudraCT Number:	2017-003843-39
Sponsor's Protocol Code Number:	LEVOCEST
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-01-17
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-003843-39

A.3

Full title of the trial

Clinical trial, Phase III, randomized, prospective, unicentric, double-blind and placebo-controlled, to estimate the efficacy and safety of intravenous Levosimendan, in the first 24 hours after primary angioplasty, in patients with acute coronary syndrome with ST-segment elevation.

Ensayo clínico, Fase III, aleatorizado, prospectivo, unicéntrico, doble ciego y controlado con placebo, para estimar la eficacia y seguridad del Levosimendan intravenoso, en las primeras 24 horas tras la Angioplastia Primaria, en pacientes con síndrome coronario agudo con elevación del segmento ST.

A.3.1

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

Clinical trial in patients who have suffered a heart attack and who have undergone catheterization treated with mild-simendan.

Ensayo clínico en pacientes que han sufrido un infarto a los que se les ha realizado un cateterismo tratados con levosimendan.

A.4.1

Sponsor's protocol code number

LEVOCEST

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	Hospital Universitario de Canarias- Dr. Francisco Bosa Ojeda
B.1.3.4	Country	Spain
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	Fundación Canaria de Investigación Sanitaria
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Complejo Hospitalario Universitario de Canarias
B.5.2	Functional name of contact point	Consuelo Rodríguez Jiménez
B.5.3	Address:
B.5.3.1	Street Address	Ofra s/n La Cuesta
B.5.3.2	Town/ city	La Laguna
B.5.3.3	Post code	38320
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034922678573
B.5.5	Fax number	0034922677284
B.5.6	E-mail	crodjimw@gobiernodecanarias.org

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	SIMDAX
D.2.1.1.2	Name of the Marketing Authorisation holder	ORION
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	LEVOSIMENDAN
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Enteral use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOSIMENDAN
D.3.9.1	CAS number	141505-33-1
D.3.9.4	EV Substance Code	SUB08493MIG
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	2.5
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

acute coronary syndrome with ST-segment elevation

síndrome coronario agudo con elevación del segmento ST

E.1.1.1

Medical condition in easily understood language

Heard Stroke

Infarto de miocardio

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	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 assess whether blunt myocardium, following acute myocardial infarction with ST-segment elevation, can be fully or partially recovered after infusion of levosimendan in the first 24 hours after primary angioplasty.

Evaluar si el miocardio contundido, tras el infarto agudo de miocardio con elevación del segmento ST, puede recuperarse total o parcialmente tras la infusión de levosimendán en las primeras 24 horas tras la angioplastia primaria

E.2.2

Secondary objectives of the trial

1. Left ventricular function.
2. Adverse ventricular remodeling.
3. Heart failure.
4. Arrhythmias.
5. Hypotension.
6. Reinfarct
7. Ischemic events.

1. Función ventricular izquierda.
2. Remodelado ventricular adverso.
3. Insuficiencia cardiaca.
4. Arritmias.
5. Hipotensión arterial.
6. Re-infarto.
7. Eventos isquémicos.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients of both sexes who come to CHUC.
Age between 18 and 85 years old.
Symptoms of STEMI over 30 minutes and less than 12 hours of evolution.
ST segment elevation of >= 1 mm in two contiguous limb leads or >= 2 mm in two contiguous precordial leads.
That they agreed to participate in the study and have signed the informed consent.
The same patient may not be included more than once.

Pacientes de ambos sexos que acudan al CHUC.
Edad comprendida entre 18 y 85 años de edad.
Síntomas de SICACEST de más de 30 minutos y menos de 12 h de evolución.
Elevación del segmento ST de ≥ 1 mm en dos derivaciones contiguas de extremidades o ≥ 2 mm en dos derivaciones contiguas precordiales.
Que aceptasen participar en el estudio y que hayan firmado el consentimiento informado.
No está permitida la inclusión del mismo paciente más de una vez.

E.4

Principal exclusion criteria

Class Killip IV in cardiogenic shock situation or with Arterial Pressure below 80 mmHg systolic pressure.
That they had a previous heart attack.
who don't have contractility disorders on their left ventriculography.
Mental circumstance that makes you unable to participate in the study.
Refuse to participate in the study and not sign an informed consent form.
Severe renal failure (creatinine clearance < 30ml/min)
Severe liver failure (define).
History of Torsades de Pointes.
Acute respiratory distress
Allergy to levosimendan or some of its components
Anemia (hemoglobin < 8g/dl)
Pregnancy

Clase Killip IV en situación de shock cardiogénico o con cifras de TA por debajo de 80 mmHg de presión sistólica.
Que hayan sufrido un infarto previo.
Que no tengan trastornos de contractilidad en la ventriculografía izquierda.
Circunstancia mental que lo incapacite para participar en el estudio.
Que rechacen participar en el estudio y que no firmen el consentimiento informado.
Insuficiencia renal grave (aclaramiento de creatinina < 30ml/min)
Insuficiencia hepática grave (definir).
Historia de Torsades de Pointes.
Distress respiratorio agudo
Alergia al levosimendan o algunos de sus componentes
Anemia (hemoglobina < 8g/dl)
Embarazo

E.5 End points

E.5.1

Primary end point(s)

Size of AMI (percentage myocardium infarct / percentage of the left ventricle) estimated by cardioresonance and quantified by late enhancement of gadolinium at 30 +/- 10 days of acute episode in both treatment, active and placebo groups.

Tamaño del IAM (porcentaje miocardio infartado / porcentaje del ventrículo izquierdo) estimado por cardiorresonancia y cuantificado por realce tardío de gadolinio a los 30 +/- 10 días del episodio agudo en ambos grupos de tratamiento, activo y placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

At 30 +/- 10 days of acute episode in both treatment, active and placebo groups.

A los 30 +/- 10 días del episodio agudo en ambos grupos de tratamiento, activo y placebo.

E.5.2

Secondary end point(s)

Echocardiographic and cardioresonance parameters related to cardiac function

Parámetros ecocardiográficos y de cardioresonancia relacionados con la función cardiaca

E.5.2.1

Timepoint(s) of evaluation of this end point

At 30 days and 6 months

A los 30 días y a los 6 meses

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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.8.5

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

Última visita del último paciente

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

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:

100

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

184

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

Ninguno

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

2018-03-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-03-26

P. End of Trial
P.	End of Trial Status	Completed

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials