Clinical Trials Register

Summary
EudraCT Number:	2011-004616-36
Sponsor's Protocol Code Number:	D5135C00001
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:	2012-11-14
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

Spain - AEMPS

A.2

EudraCT number

2011-004616-36

A.3

Full title of the trial

A randomized, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (EUCLID Examining Use of tiCagreLor In paD)

Ensayo Fase IIIb, aleatorizado, doble ciego, de grupos paralelos, multicéntrico, para comparar el riesgo de muerte cardiovascular, infarto de miocardio e ictus isquémico en pacientes con enfermedad arterial periférica establecida, tratados con ticagrelor vs clopidogrel (EUCLID- Examinando el Uso de tiCagreLor en EAP).

A.3.1

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

A study comparing cardiovascular effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease

Estudio que compara los efectos cariovasculares de ticagrelor y clopidogrel en pacientes con enfermedad arterial periférica

A.3.2

Name or abbreviated title of the trial where available

EUCLID

A.4.1

Sponsor's protocol code number

D5135C00001

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	AstraZeneca AB
B.1.3.4	Country	Sweden
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	AstraZeneca AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca
B.5.2	Functional name of contact point	Information Centre
B.5.3	Address:
B.5.3.1	Street Address	1800 Concord Pike, PO Box 15437
B.5.3.2	Town/ city	Wilmington
B.5.3.3	Post code	19850-5437
B.5.3.4	Country	United States
B.5.4	Telephone number	0018002369933
B.5.5	Fax number	na
B.5.6	E-mail	information.center@astrazeneca.com

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
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
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.3.1	Product name	Ticagrelor de 90 mg Comprimidos recubiertos con pelicula
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.3.9.1	CAS number	274693-27-5
D.3.9.2	Current sponsor code	AZD6140
D.3.9.3	Other descriptive name	TICAGRELOR
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	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.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	PLAVIX
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI
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	Plavix (bisulfato de clopidogrel) comprimidos 75mg
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	Cloropidogrel Bisulfate
D.3.9.2	Current sponsor code	Cloropidogrel Bisulfate
D.3.9.3	Other descriptive name	Cloropidogrel Bisulfate
D.3.9.4	EV Substance Code	SUB12483MIG
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	75
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	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
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

Peripheral artery disease

Enfermedad arterial períferica

E.1.1.1

Medical condition in easily understood language

Claudication

Claudicación

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10067825
E.1.2	Term	Peripheral arterial disease
E.1.2	System Organ Class	100000004866

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. clopidogrel on the event rate of the composite of CV death, MI and ischemic stroke in patients with established PAD.

El objetivo principal del ensayo es comparar el efecto del tratamiento a largo plazo con ticagrelor en comparación con clopidogrel sobre la tasa de acontecimientos de la combinación de muerte cardiovascular (CV), infarto de miocardio (IM) e ictus isquémico (definido como cualquier ictus que no se haya demostrado que es fundamentalmente hemorrágico) en pacientes con enfermedad arterial periférica (EAP) demostrada

E.2.2

Secondary objectives of the trial

To compare the effect of long-term treatment with ticagrelor vs. clopidogrel in patients with established PAD
1. Composite of CV death and MI
2. CV death
3. MI
4. All-cause mortality
5. Composite of CV death, MI, and all cause stroke
6. All revascularisation

Comparar el efecto del tratamiento prolongado con ticagrelor en comparación con clopidogrel en pacientes con EAP establecida
1. Combinación de muerte CV e IM
2. Muerte CV
3. IM
4. La tasa de mortalidad por todas las causas
5. Combinación de muerte CV, IM e ictus de cualquier causa
6. Toda revascularización

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and Female patients 50 years old or older
2. Symptomatic peripheral artery disease

1.Hombres y mujeres de ?50 años
2. Enfermedad arterial periférica

E.4

Principal exclusion criteria

1. Patients needing dual anti-platlet drug treatment before start of study
2. Planned revascularisation or amputation
3. Patients with known bleeding disorders
4. Patients with a history of intracranial bleed
5. Patients considered to be at risk of bradycardic events unless already treated with a permanent pacemaker

1.Pacientes que precisan doble tratamiento antiagregante en el momento de la inclusión en el ensayo.
2.Revascularización o amputación programada
3. Pacientes con hemorragia sistemática.
4. Pacientes con Antecedentes de hemorragia intracraneal
5.Pacientes considerados de riesgo de episodios bradicárdicos salvo que se les haya implementado un marcapasos permanente

E.5 End points

E.5.1

Primary end point(s)

Any event after randomization from the composite of cardiovascular death, myocardial infarction and ischemic stroke

Cualquier acontecimiento por la combinación de muerte CV, IM e ictus isquémico, posterior a la aleatorización

E.5.1.1

Timepoint(s) of evaluation of this end point

Up to approximately 37 months

Aproximadamente 37 meses

E.5.2

Secondary end point(s)

Composite of cardiovascular death and myocardial infarction after randomization.
Cardiovascular death after randomization.
Myocardial infarction after randomization.
All-cause mortality after randomization.
Cardiovascular death, myocardial infarction and all-cause stroke (ischaemic or haemorrhagic) after randomization.
All revascularisation after randomization

Combinación de Muerte cardiovascular e infarto de miocardio despues de la aletatorizacion.
Muerte cardiovascular despues de la aletatorizacion.
Infarto de miocardio despues de la aletatorizacion.
Mortalidad por todas las causas despues de la aleatorizacion Muerte CV, IM e ictus de cualquier causa (isquémico o hemorrágico) despues de la aleatorizacion.
Toda revascularización despues de la aleatorizacion.

E.5.2.1

Timepoint(s) of evaluation of this end point

Up to approximately 37 months

Aproximadamente 37 meses

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

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)

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

260

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Brazil

Canada

Chile

China

Japan

Korea, Republic of

Mexico

Philippines

Russian Federation

Thailand

Turkey

Ukraine

United States

Vietnam

E.8.7

Trial has a data monitoring committee

Yes

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

Planned LSLV study completion date: 2016-01-07

Fecha planeada de la última visita del último paciente: 01-07-2016

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:

4600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

6900

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

225

F.4.2

For a multinational trial

F.4.2.1

In the EEA

4695

F.4.2.2

In the whole clinical trial

11500

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)

Standard of care

Práctica Clínica Habitual

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

2012-11-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-08

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

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