Clinical Trials Register

Summary
EudraCT Number:	2012-000497-38
Sponsor's Protocol Code Number:	VERDI
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:	2012-05-11
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

2012-000497-38

A.3

Full title of the trial

VERDI Study (VERifynow in Diabetes non-responsiveness: a study on switching from Clopidogrel to Prasugrel). A randomized, mono-center study comparing the treatment plan of a loading dose of prasugrel as opposed to the standard dose in type 2 diabetic patients, who suffer acute coronary syndrome, revascularized through an invasive percutaneous strategy with a stent.

Estudio aleatorizado, unicéntrico, que compara un régimen de dosis de carga de prasugrel (60 mg) y posterior dosis de mantenimiento (10 mg) frente al régimen con dosis estándar de clopidogrel (75 mg) en pacientes diabéticos tipo 2 no respondedores a clopidogrel revascularizados mediante una estrategia invasiva percutanea con stent farmacoactivo. Estudio VERDI (VERifynow in non-responsiveness DIabetes for switching Clopidogrel to Prasugrel study)

A.3.1

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

VERDI Study (VERifynow in Diabetes non-responsiveness: a study on switching from Clopidogrel to Prasugrel).

Estudio VERDI (VERifinow en DIabéticos no respondedores: un estudio sobre el paso de clopidogrel a prasugrel)

A.3.2

Name or abbreviated title of the trial where available

VERDI

A.4.1

Sponsor's protocol code number

VERDI

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	Fundación FISEVI
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	Consejeria de salud
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	Fundación FISEVI
B.5.2	Functional name of contact point	Clara Rosso Fernández
B.5.3	Address:
B.5.3.1	Street Address	Avda. Manuel Siurot s/n
B.5.3.2	Town/ city	Seville
B.5.3.3	Post code	41013
B.5.3.4	Country	Spain
B.5.4	Telephone number	34955013414
B.5.5	Fax number	34954232992
B.5.6	E-mail	claram.rosso.sspa@juntadeandalucia.es

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	Efient
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B:V
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	Efient
D.3.4	Pharmaceutical form	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	PRASUGREL
D.3.9.1	CAS number	150322-43-3
D.3.9.4	EV Substance Code	SUB30236
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	10 to mg
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	AGRELAN
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	AGRELAN
D.3.4	Pharmaceutical form	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	CLOPIDOGREL
D.3.9.1	CAS number	113665-84-2
D.3.9.4	EV Substance Code	SUB13395MIG
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 to mg
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

Type 2 diabetic patients revascularized with a stent, who have an acute coronary syndrome without persistent ST segment elevation.

Pacientes diabéticos tipo 2 con infarto agudo de miocardio sin elevación de ST sometidos a revascularización con stent.

E.1.1.1

Medical condition in easily understood language

Diabetic patients with myocardial infarction revascularized with a stent.

Pacientes diabéticos con infarto de miocardio tratados mediante implante de stent.

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

To determine if, in type 2 diabetic patients undergoing treatment with PCI and a stent, who fail to respond to normal doses of clopidogrel, a loading dose of 60 mg of prasugrel followed by 10 mg once daily is superior to the standard dose of 75 mg of clopidogrel in achieving greater than 50% inhibition of platelet aggregation at 24-36 hours of treatment.

Determinar si en pacientes diabe?ticos tipo 2 no respondedores al clopidogrel en las dosis habituales, que reciben tratamiento mediante un intervencionismo coronario percuta?neo (ICP) con stent, un re?gimen con dosis de carga (60 mg) de prasugrel seguido de 1cp (10 mg) una vez al di?a, es superior a la dosis esta?ndar de 75 mg en conseguir una respuesta antiagregante mediada por clopidogrel superior a un 50% medida a las 24-36 horas de tratamiento.

E.2.2

Secondary objectives of the trial

To evaluate the safety of a treatment plan with a loading dose of prasugrel in comparison with the treatment plan of the standard dose of clopidogrel in terms of the appearance of secondary effects of clopidogrel (severe bleeding, thrombocytopenia, neutropenia, gastrointestinal changes, thrombotic thrombocytopenic purpura).

Evaluar la seguridad del re?gimen prasugrel en comparacio?n con el re?gimen de dosis esta?ndar en cuanto a la aparicio?n de efectos secundarios del clopidogrel (hemorragia severa, trombocitopenia, neutropenia, alteraciones gastrointestinales, pu?rpura trombocitope?nica trombo?tica).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Type 2 diabetic patients with acute coronary syndrome with non-ST segment elevation who are undergoing a percutaneous coronary intervention (PCI) with a coronary stent.
2. Patients who are non-responsive on the platelet anti-aggregation test with standard doses of clopidogrel will be randomized.
3. Participants must sign an informed consent document.

1. Pacientes diabe?ticos tipo 2, que han sufrido un si?ndrome coronario agudo sin elevacio?n de ST a quienes se ha realizado una intervencio?n coronaria percuta?nea (ICP) mediante stents coronario.
2. Los pacientes aleatorizados sera?n aquellos no respondedores en los test de antiagregacio?n plaquetaria a las dosis esta?ndar de clopidogrel.
3. Deben firmar el consentimiento informado.

E.4

Principal exclusion criteria

1. Age <18 years or >80 years.
2. Patients with acute coronary syndrome with ST segment elevation.
3. Pregnancy previous to or during the study.
4. The use of oral anticoagulants in the last 10 days with an INR >1.5 or who plan to use them during the follow-up
period (1 year).
5. Antithrombotic treatment with GP IIb/IIIa inhibitors.
6. Contraindication for the use of prasugrel and/or clopidogrel and/or aspirin:
? Antecedents of pharmacologic allergy to thienopyridine derivatives or aspirin.
? Antecedents of clinically significant or persistent thrombocytopenia or neutropenia.
7. Active bleeding or significant increase of risk of hemorrhage such as severe hepatic insufficiency, peptic ulcer present, proliferative diabetic retinopathy, antecedents of severe systemic bleeding, gastrointestinal bleeding, macrohematuria, intraocular hemorrhage, hemorrhagic stroke, or intracranial bleeding), or other antecedents of bleeding diathesis or coagulopathy.
8. Patients >75 years of age.
9. Patients with previous TIA or CVA.
10. Patients weighing <60 Kg.
11. Hemoglobin <10.5 g/dl, or Hematocrit <30%.
12. Severe left ventricular systolic dysfunction, EF <35%.
13. Renal insufficiency with creatinine levels >2 mg/dl.
14. Previous inclusion of the patient in another study.
15. Treatment in research (medication or device) in the last 30 days prior.
16. Medical, geographical, or social factors that would make participation in the study impractical, such as the incapacity to provide written informed consent and to understand the complete meaning of informed consent, or the refusal of the patient to participate in the study.

1. Edad < 18 an?os o >80 an?os.
2. Pacientes con si?ndrome coronario agudo con elevacio?n del segmento ST.
3. Embarazo previo o durante el estudio.
4. Utilizacio?n de anticoagulantes orales en los u?ltimos 10 di?as con un INR > 1,5 o que tengan previsto
utilizarlos durante el periodo de seguimiento (1 an?o).
5. La terapia antitrombo?tica con inhibidores de GP IIa/IIIb.
6. Contraindicacio?n a la utilizacio?n de prasugrel y/o clopidogrel y/o AAS:
? Antecedentes de alergia farmacolo?gica a derivados de tienopiridina o AAS.
? Antecedentes de trombocitopenia o neutropenia cli?nicamente significativa o persistente.
7. Hemorragia activa o aumento significativo del riesgo de hemorragia, como insuficiencia hepa?tica severa, u?lcera pe?ptica presente, retinopati?a diabe?tica proliferativa, antecedentes de hemorragia siste?mica severa (hemorragia gastrointestinal, macrohematuria, hemorragia intraocular, ictus hemorra?gico, o hemorragia intracraneal), u otros antecedentes de dia?tesis hemorra?gica o coagulopati?a.
8. Pacientes > 75 an?os.
9. Pacientes con AIT o A VC previos.
10. Pacientes con peso < 60 Kg.
11. Hemoglobina <10,5 g/dl, o? Hematocrito <30%.
12. Disfuncio?n sisto?lica de ventri?culo izquierdo severa, FE <35%.
13. Insuficiencia renal con niveles de creatinina >2 mg/dl.
14. Inclusio?n previa del paciente en otro estudio.
15. Tratamiento en investigacio?n (fa?rmaco o dispositivo) en los 30 di?as previos.
16. Factores me?dicos, geogra?ficos o sociales que conviertan la participacio?n en el estudio en impracticable, asi? 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)

Level of platelet aggregation inhibition at 24-36 hours post-PCI (Percutaneous Coronary Interventionism)in both groups (standar dose of clopidogrel vs loading dose of 60 mg of prasugrel followed by 10 mg daily). The level of platelet aggregation inhibition will be assessed by VerifyNow assay.

Estado de agregación plaquetaria a las 24-36 horas del intervencionismo percutáneo en ambos grupos (clopidogrel a dosis estandar vs dosis de carga de 60 mg de prasugrel seguidos de 10 mg diarios). Este estado de agregación plaquetaria será determinado mediante el test VerifyNow P2Y12 assay

E.5.1.1

Timepoint(s) of evaluation of this end point

24-36 hours post-PCI (Percutaneous Coronary Interventionism

24-36 horas tras intervencionismo coronario percutáneo.

E.5.2

Secondary end point(s)

Occurrence and severity of adverse events.

Aparicion y gravedad de acontecimientos adversos.

E.5.2.1

Timepoint(s) of evaluation of this end point

No Aplica

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

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

Yes

E.8.1.4

Double blind

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

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

The trial will end once 50 patients have been recruited.

El estudio terminará una vez 50 pacientes hayan sido reclutados.

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:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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.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)

The expected normal treatment of myocardial infarction.

El tratamiento habitual del infarto de miocardio.

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

2012-07-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-30

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

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