Clinical Trials Register

Summary
EudraCT Number:	2015-001808-57
Sponsor's Protocol Code Number:	BICATOR
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2015-10-30
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

Spain - AEMPS

A.2

EudraCT number

2015-001808-57

A.3

Full title of the trial

Assessment of atorvastatin efficacy on the progression of aortic dilatation and valvular degeneration in patients with bicuspid aortic valve (BICATOR)

Evaluación de la eficacia de la Atorvastatina en la progresión de la dilatación aórtica y la degeneración valvular en pacientes con válvula aortica bicúspide (BICATOR)

A.3.1

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

Assessment of atorvastatin efficacy on the progression of aortic dilatation and valvular degeneration in patients with bicuspid aortic valve (BICATOR)

Evaluación de la eficacia de la Atorvastatina en la progresión de la dilatación aórtica y la degeneración valvular en pacientes con válvula aortica bicúspide (BICATOR)

A.3.2

Name or abbreviated title of the trial where available

BICATOR

A.4.1

Sponsor's protocol code number

BICATOR

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	Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
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	Instituto de Salud Carlos III (ISCIII)
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	Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
B.5.2	Functional name of contact point	Artur Evangelista Masip
B.5.3	Address:
B.5.3.1	Street Address	Paseo Valle de Hebron 119-129
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08035
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3493489 41 84
B.5.5	Fax number	+3493274 60 636063
B.5.6	E-mail	m.angeles.carmona@vhir.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	Atorvastatin 20 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	LABORATORIOS NORMON, SA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.11 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	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Valve Disease

Enfermedad de Válvular

E.1.1.1

Medical condition in easily understood language

Valve Disease

Enfermedad Valvular

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	18.1
E.1.2	Level	SOC
E.1.2	Classification code	10007541
E.1.2	Term	Cardiac disorders
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 determine whether treatment with atorvastatin is effective in reducing the progression of aortic dilatation in patients with bicuspid aortic valve.

-Determinar si el tratamiento con atorvastatina es eficaz en la reducción de la progresión de la dilatación aórtica en pacientes con válvula aórtica bicúspide.

E.2.2

Secondary objectives of the trial

-To Define whether atorvastatin treatment slows the progression of valvular degeneration (valvular calcification)
- To Define whether treatment with atorvastatin reduces clinical events during 3 years of follow-up.

-Definir si el tratamiento con atorvastatina enlentece la progresión de la degeneración valvular (calcificación valvular)
-Definir si el tratamiento con atorvastatina reduce los eventos clínicos durante 3 años de seguimiento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patients ? 18 years with bicuspid aortic valve confirmed by TTE (in case of doubt the use of other imaging techniques require: TEE or CT to confirm the diagnosis).
-Disfunción Valve only moderate: in case of aortic stenosis with average <20 mmHg gradient and in case of aortic insufficiency with contracta <5 vein or jet width <7.
-Aortic valve not show more light spots of calcification transthoracic study.
-Diámetros Level aortic ascending aorta (sinus of Valsalva or tubular ascending aorta) ? 21mm / m2 but not reach 50 mm.
-To Written informed consent.

-Pacientes ? 18 años con válvula aórtica bicúspide confirmado por ETT (en caso de dudas se requerirá el uso de otras técnicas de imagen: ETE o TC para confirmación del diagnóstico).
-Disfunción valvular no más que moderada: en caso de estenosis aórtica con gradiente medio <20mmHg y en caso de insuficiencia aórtica con vena contracta < 5 o anchura del jet < 7.
-Válvula aórtica que no muestre más que ligeros puntos de calcificación al estudio transtorácico.
-Diámetros aórticos a nivel de aorta ascendente (Senos de Valsalva o aorta ascendente tubular) ? 21mm/m2 pero sin alcanzar los 50 mm.
-Otorgar el consentimiento informado por escrito.

E.4

Principal exclusion criteria

- Patients <18 years
- Patients with uncontrolled hypertension and a history or risk of diabetes mellitus
- Patients who are treated with statins or other lipid-lowering drug or have it as indication for clinical practice guidelines.
- History of heart surgery or any segment of the aorta
- A history of aortic dissection and / or aortic coarctation
- Functional Class III-IV
- History or presence of hepatic impairment (serum transaminases> 2times the upper limit of normal by each laboratory), renal (creatinine clearance <30 ml / min or creatinine> 2.5mg / dl), myopathy myopathy or creatine kinase levels> 5 times the ULN, and other gastrointestinal diseases, hematologic, endocrine or any other situation which in the opinion of the researcher may affect the assessment of study treatment
- Hypersensitivity or intolerance to any component of the study drug or to intravenous contrast used in the TC
- Pregnancy, lactation or gestational desire during the test period. In all women of childbearing age, a result of negative gonadotropin be required in the pregnancy test for entry into the study.
- Ongoing Participation in another clinical trial

-Pacientes <18 años
- Pacientes con hipertensión arterial no controlada y antecedentes o riesgo de diabetes mellitus.
-Pacientes que reciben tratamiento con estatinas u otro fármaco hipolipemiante o tienen indicación para ello según guías de práctica clínica.
-Antecedentes de cirugía cardiaca o en cualquier segmento de la aorta
-Antecedentes de disección aórtica y/o coartación aórtica
-Clase funcional III- IV
-Antecedentes o presencia de insuficiencia hepática (transaminasas séricas >2veces el límite superior de la normalidad según cada laboratorio), renal (aclaramiento de creatinina <30ml/min o creatinina>2.5mg/ dl), miopatía miopatía o niveles de creatina quinasa > 5 veces el valor máximo de normalidad, u otras enfermedades gastrointestinal, hematológica, endocrina o cualquier otra situación que a criterio del investigador pueda afectar la evaluación del tratamiento en estudio
-Hipersensibilidad, intolerancia o contraindicación a alguno de los componentes del fármaco en estudio o al contraste endovenoso utilizado en el TC
-Embarazo, lactancia o deseo gestacional durante la duración del ensayo. En todas aquellas mujeres en edad fértil, se requerirá un resultado de gonadotropina negativa en la prueba de embarazo para su entrada en el estudio.
-Participación en curso en otro ensayo clínico

E.5 End points

E.5.1

Primary end point(s)

Determination of the progression of aortic dilatation of the ascending aorta by measuring the change in diameter of the ascending aorta by CT in three years follow-up. The change in aortic diameter is defined by most of the differences between the measurements taken at the level of the aortic root and ascending aorta at baseline and end of study.

Determinación de la progresión de la dilatación aórtica en aorta ascendente mediante la medición del cambio del diámetro de la aorta ascendente por TC en 3 años de seguimiento. El cambio del diámetro aórtico se definirá por la mayor de las diferencias entre las medidas realizadas a nivel de la raíz aórtica y la aorta ascendente en el estudio basal y final.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 years

3 años

E.5.2

Secondary end point(s)

3 years

3 años

E.5.2.1

Timepoint(s) of evaluation of this end point

3 years

3 años

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

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

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

Last patient`s last visit

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:

180

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

220

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)

Nothing different from the expected normal treatment of that condition

Nada diferente del tratamiento en estas condiciones

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

2015-11-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-09

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

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