Clinical Trial Page

Summary
EudraCT Number:2004-001943-31
Sponsor's Protocol Code Number:SEC-2004-001
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:2004-11-25
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2004-001943-31
A.3Full title of the trial
ESTUDIO ALEATORIZADO PARA COMPARAR LA EFICACIA Y SEGURIDAD DE LA FIBRINOLISIS O LA ANGIOPLASTIA PRIMARIA COMO TRATAMIENTO INICIAL DE REPERFUSIÓN EN LOS PACIENTES DE EDAD AVANZADA (>/=75 AÑOS) CON INFARTO AGUDO DE MIOCARDIO
A.3.2Name or abbreviated title of the trial where available
TRIANA
A.4.1Sponsor's protocol code numberSEC-2004-001
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorSociedad Española de Cardiología
B.1.3.4CountrySpain
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Metalyse 10.000U (1)
D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameTenecteplase
D.3.2Product code EU/1/00/169/003 EU/1/00/169/006
D.3.4Pharmaceutical form Anticoagulant and preservative solution for blood
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNTenecteplase
D.3.9.1CAS number 191588-94-0
D.3.10 Strength
D.3.10.1Concentration unit IU international unit(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number10.000
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.1.1.1Trade name Metalyse 8.000U (2)
D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameTenecteplase
D.3.2Product code EU/1/00/169/002 EU/1/00/169/005
D.3.4Pharmaceutical form Anticoagulant and preservative solution for blood
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNTenecteplase
D.3.9.1CAS number 191588-94-0
D.3.10 Strength
D.3.10.1Concentration unit IU international unit(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number8.000
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another 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.1.1Medical condition(s) being investigated
Acute Myocardial infarction
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version M15
E.1.2Level PT
E.1.2Classification code 10028597
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Objetivo general: Comparar la eficacia y seguridad de la angioplastia primaria y el tratamiento fibrinolítico en pacientes >/=75 años de edad con IAM elegibles para fibrinolisis en centros españoles con programas activos de angioplastia primaria.

Objetivo primario: Incidencia del agregado de muerte de cualquier causa, reinfarto o ACV incapacitante a los 30 días.
E.2.2Secondary objectives of the trial
·Mortalidad de cualquier causa a los 30 días
·Muerte de cualquier causa, ACV incapacitante o insuficiencia cardíaca nueva a los 30 días
·Isquemia recurrente que lleva a realización de cateterismo urgente en los primeros 30 días
·Causa de muerte a los 30 días (Clasificadas en tres grupos: 1) Shock o fallo de bomba; 2) Complicaciones mecánicas [roturas] o disociación electromecánica; 3) Otras causas [incluidas hemorragias])
·Incidencia de hemorragias mayores durante el ingreso hospitalario
·Mortalidad de cualquier causa a los 12 meses
·Tiempo hasta la aparición de cualquiera del agregado de muerte de cualquier causa, reinfarto o ACV incapacitante a los 12 meses
·Tiempo hasta la aparición de cualquiera del agregado de muerte de cualquier causa, reinfarto, ACV incapacitante o rehospitalización no electiva de causa cardíaca (angina inestable, insuficiencia cardíaca, revascularización coronaria no electiva) a los 12 meses
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
1.Edad de 75 ó más años
2.Presentar un diagnóstico de IAM: Dolor torácico u otro síntoma compatible con isquemia miocárdica de, al menos, 20 minutos de duración, que no cede con nitratos y cuyo tiempo de evolución es menor de 6 horas desde el inicio de los síntomas, con una de los siguientes alteraciones:
a.Elevación del segmento ST >/= 2 mm en dos o más derivaciones precordiales
b.Elevación del segmento ST >/= 1 mm en dos o más derivaciones frontales
c.Bloqueo completo de rama izquierda del haz de Hiss nuevo o presumiblemente nuevo
3.Ser capaz de proporcionar un consentimiento informado antes de la aleatorización y estar de acuerdo en cumplir todos los procedimientos incluidos en el protocolo, incluida la fase de seguimiento posthospitalaria. Un consentimiento escrito por un familiar cercano con testigos también es aceptable.
E.4Principal exclusion criteria
1.Contraindicación formal para el empleo de fibrinolíticos
1.1.Sangrado activo interno o historia conocida de diátesis hemorrágica
1.2.Historia de ACV previo de cualquier tipo y en cualquier momento
1.3.Tumor intracraneal, malformación arterio-venosa, aneurisma o reparación de aneurisma cerebral
1.4.Cirugía mayor, biopsia de un parénquima, cirugía ocular o traumatismo severo en las 6 semanas previas a la aleatorización
1.5.Punción de un vaso no compresible en las 24 horas previas a la aleatorización
1.6.Hipertensión confirmada con una medida fiable de TA sistólica >180 mmHg
1.7.Trombocitopenia conocida < 100.000 plaquetas/mL
1.8.Resucitación cardiopulmonar prolongada (>20 minutos) o traumática en las 2 semanas previas a la aleatorización
1.9.Historia o signos sugestivos de disección aórtica
2.Shock cardiogénico
3.Tiempo estimado de realización del procedimiento mayor de 120 minutos
4.Uso de un fibrinolítico en los 14 días previos a la aleatorización
5.Uso de cualquier inhibidor de la glicoproteína IIb/IIIa en las 24 horas previas a la aleatorización
6.Uso de cualquier heparina de bajo peso molecular en las 8 horas previas a la aleatorización
7.Tratamiento anticoagulante oral actual
8.Sospecha de IAM secundario a oclusión de una lesión tratada previamente mediante intervencionismo percutáneo (en los 30 días previos para angioplastia o stent convencional y en los 12 meses previos para stent recubierto)
9.Demencia o cuadro confusional agudo en el momento de la aleatorización
10.Incapacidad o no deseo de dar el consentimiento informado, al menos verbal
11.Insuficiencia renal conocida (creatinina basal > 2,5 mg/dl)
12.Expectativa de vida reducida (<12 meses) por presencia de enfermedades concomitantes avanzadas o terminales
13.Participación en otro ensayo clínico (que evalúe un fármaco o dispositivo) en los 30 días previos a la aleatorización
E.5 End points
E.5.1Primary end point(s)
Incidencia del agregado de muerte de cualquier causa, reinfarto o ACV incapacitante a los 30 días
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
Primary Coronary Angioplasty
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial 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
Last patient out of the trial
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months7
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years2
E.8.9.2In all countries concerned by the trial months7
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state570
F.4.2 For a multinational trial
F.4.2.1In the EEA 570
F.4.2.2In the whole clinical trial 570
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-12-17
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2004-11-26
P. End of Trial
P.End of Trial StatusOngoing

Sponsors and Collaborators

Medical Conditions

Drug Interventions

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