Clinical Trials Register

Summary
EudraCT Number:	2007-003907-11
Sponsor's Protocol Code Number:	ICP-2007/00
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:	2008-01-17
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

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2007-003907-11

A.3

Full title of the trial

Estudio aleatorizado, unicéntrico, que compara un régimen de dosis elevada de clopidogrel frente a la dosis estándar en pacientes diabéticos tipo 2 revascularizados mediante una estrategia invasiva percutanea con stent farmacoactivo." Estudio CANDY (Clopidogrel and Aspirin No responsiveness in Diabetes tYpe 2 study).

A.3.2

Name or abbreviated title of the trial where available

CANDY

A.4.1

Sponsor's protocol code number

ICP-2007/00

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Grupo de Investigación ICP
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Information not present in EudraCT
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	Clopidogrel
D.3.2	Product code	Clopidogrel
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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	CLOPIDOGREL
D.3.9.1	CAS number	113665-84-2
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Information not present in EudraCT

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

Síndrome coronario agudo (angina inestable / infarto agudo de miocardio sin elevación de ST) en combinación con Ácido Acetilsalicílico

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

Determinar si en pacientes diabéticos tipo 2 no respondedores al ácido acetilsalicílico ni al clopidogrel en las dosis habituales, que reciben tratamiento mediante un intervencionismo coronario percutáneo (ICP) con stent farmacoactivo, un régimen de dosis altas de clopidogrel con 150 mg una vez al día, es superior a la dosis estándar de 75 mg, en conseguir una respuesta antiagregante mediada por clopidogrel superior a un 50% medida a los 30 días de tratamiento.

E.2.2

Secondary objectives of the trial

1. Evaluar la seguridad del régimen de dosis alta de clopidogrel en comparación con el régimen de dosis estándar en cuanto a la aparición de efectos secundarios del clopidogrel (hemorragia severa, trombocitopenia, neutropenia, alteraciones gastrointestinales, púrpura trombocitopénica trombótica).
2. Evaluar los resultados en los diferentes subgrupos, y analizar el endpoint combinado de muerte cardiovascular, IM, ictus o isquemia recurrente, a los 30 días, 12 meses, 24 meses
3. Analizar las características de los pacientes no respondedores a la doble antiagregación.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Pacientes diabéticos tipo 2 que han sufrido un síndrome coronario agudo sin elevación de ST, a quienes se ha realizado una intervención coronaria percutánea (ICP) mediante stents farmacoactivos Xience V.
2. Los pacientes aleatorizados serán aquellos no respondedores en los test de antiagregación plaquetaria a las dosis estándar de aspirina y clopidogrel.
3. Deben firmar el consentimiento informado.

E.4

Principal exclusion criteria

1. Edad < 18 años o >80 años.
2. Pacientes con síndrome coronario agudo con elevación del segmento ST.
3. Embarazo previo o durante el estudio.
4. Utilización de anticoagulantes orales en los últimos 10 días con un INR > 1,5 o que tengan previsto utilizarlos durante el periodo de seguimiento (1 año).
5. La terapia antitrombótica con inhibidores de GP IIa/IIIb.
6. Contraindicación a la utilización de clopidogrel y/o AAS:
7. Antecedentes de alergia farmacológica a derivados de tienopiridina o AAS.
8. Antecedentes de trombocitopenia o neutropenia clínicamente significativa o persistente.
9. Hemorragia activa o aumento significativo del riesgo de hemorragia, como insuficiencia hepática severa, úlcera péptica presente, retinopatía diabética proliferativa, antecedentes de hemorragia sistémica severa (hemorragia gastrointestinal, macrohematuria, hemorragia intraocular, ictus hemorrágico, o hemorragia intracraneal), u otros antecedentes de diátesis hemorrágica o coagulopatía.
10. Hemoglobina <12 g/dl, ó Hematocrito <35%.
11. Disfunción sistólica de ventrículo izquierdo severa, FE <35%.
12. Insuficiencia renal con niveles de creatinina >2 mg/dl.
13. Inclusión previa del paciente en otro estudio.
14. Tratamiento en investigación (fármaco o dispositivo) en los 30 días previos.
15. Factores médicos, geográficos o sociales que conviertan la participación en el estudio en impracticable, así como incapacidad para dar el consentimiento informado por escrito y para entender el significado completo del consentimiento informado, o bien negativa del paciente a participar en el estudio.

E.5 End points

E.5.1

Primary end point(s)

Estado de agregación plaquetaria al mes de tratamiento en ambos grupos (dosis estándar vs dosis alta de clopidogrel). Este estado de agregación plaquetaria será determinado mediante el test VerifyNow P2Y12 assay

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Evaluación ciega por terceros

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

dosis estándar mismo fármaco

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

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

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

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	No
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	40

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

2008-01-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-10-08

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

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