Clinical Trials Register

Summary
EudraCT Number:	2013-001384-23
Sponsor's Protocol Code Number:	REG1-CLIN310
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2013-12-05
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

2013-001384-23

A.3

Full title of the trial

A RANDOMIZED, OPEN-LABEL, MULTI-CENTER, ACTIVE-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY AND SAFETY OF THE REG1 ANTICOAGULATION SYSTEM COMPARED TO BIVALIRUDIN IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION

Estudio aleatorizado, abierto, multicéntrico, comparativo con tratamiento activo, de grupos paralelos, para determinar la eficacia y seguridad del sistema de anticoagulación REG1 en comparación con bivalirudina en pacientes sometidos a una intervención coronaria percutánea

A.3.1

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

A study to evaluate the efficacy and safety of a new anticoagulation drug
REG1 compared with bivalirudin in patients undergoing angioplasty.

Estudio para determinar la eficacia y seguridad de un nuevo medicamento anticoagulante REG1 en comparación con bavalirudina en pacientes sometidos a angioplastia.

A.4.1

Sponsor's protocol code number

REG1-CLIN310

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	Regado Biosciences, Inc.
B.1.3.4	Country	United States
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	Regado Biosciences, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Regado Biosciences, Inc.
B.5.2	Functional name of contact point	Raul Lima - Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	120 Mountain View Boulevard
B.5.3.2	Town/ city	Basking Ridge
B.5.3.3	Post code	New Jersey 0792
B.5.3.4	Country	United States
B.5.4	Telephone number	001-908-580-2116
B.5.5	Fax number	001-908-325-0370
B.5.6	E-mail	rlima@regadobio.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	No
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	pegnivacogin
D.3.2	Product code	REG 1
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pegnivacogin
D.3.9.2	Current sponsor code	RB006
D.3.9.3	Other descriptive name	R01AZ
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	24
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	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	No
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	anivamersen
D.3.2	Product code	REG 1
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	anivamersen
D.3.9.2	Current sponsor code	RB007
D.3.9.3	Other descriptive name	R01J
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	48
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: 3
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	Angiox
D.2.1.1.2	Name of the Marketing Authorisation holder	The Medicines Company UK Ltd
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	Angiox
D.3.4	Pharmaceutical form	Lyophilisate for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BIVALIRUDIN
D.3.9.1	CAS number	128270-60-0
D.3.9.4	EV Substance Code	SUB05862MIG
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	250
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

Coronary Artery Disease (CAD) in patients undergoing Percutaneous Coronary Intervention (PCI)

Pacientes con Enfermedad Coronaria (EC) sometidos a Intervención Coronaria Percutánea (ICP)

E.1.1.1

Medical condition in easily understood language

Coronary Artery Disease (CAD) in patients undergoing Percutaneous Coronary Intervention (PCI)

Pacientes con Enfermedad Coronaria (EC) sometidos a Intervención Coronaria Percutánea (ICP)

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	HLT
E.1.2	Classification code	10011085
E.1.2	Term	Ischaemic coronary artery disorders
E.1.2	System Organ Class	100000004849

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 the efficacy of REG1 compared to bivalirudin in patients with coronary artery disease (CAD) undergoing Percutaneous Coronary Intervention (PCI) for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent target lesion revascularization (TLR) through Day 3.

Determinar la eficacia de REG1 en comparación con bivalirudina en pacientes con enfermedad coronaria (EC) sometidos a una Intervención Coronaria Percutánea (ICP) para prevenir la combinación de muerte, infarto de miocardio no mortal, ictus no mortal y revascularización de la lesión diana (TLR) urgente hasta el Día 3.

E.2.2

Secondary objectives of the trial

1. Determine the efficacy of REG1 compared to bivalirudin for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke, urgent TLR and stent thrombosis (including intra-procedural) through Day 3.
2. Determine the safety of REG1 compared to bivalirudin on major hemorrhagic complications of PCI through Day 3 and Day 30.
3. Determine the efficacy of REG1 compared to bivalirudin for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 30.
4. Determine the efficacy of REG1 compared to bivalirudin in cardiac biomarker-positive patients for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.
5. Determine the efficacy of REG1 compared to bivalirudin in cardiac biomarker-negative patients for preventing the composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.

1. Determinar eficacia de REG1 en comparación con bivalirudina para prevenir la combinación de muerte, IM no mortal, ictus no mortal, TLR urgente y trombosis del stent (incluyendo la intraoperatoria) hasta el Día 3.
2. Determinar seguridad de REG1 en comparación con bivalirudina en complicaciones hemorrágicas mayores de la ICP hasta el Día 3 y el Día 30.
3. Determinar eficacia de REG1 en comparación con bivalirudina para prevenir la combinación de muerte, IM no mortal, ictus no mortal y TLR urgente hasta el Día 30.
4. Determinar eficacia de REG1 en comparación con bivalirudina en pacientes con biomarcadores cardíacos positivos sometidos a una ICP para prevenir la combinación de muerte, IM no mortal, ictus no mortal y TLR urgente hasta el Día 3.
5. Determinar eficacia de REG1 en comparación con bivalirudina en pacientes con biomarcadores cardíacos negativos sometidos a una ICP para prevenir la combinación de muerte, IM no mortal, ictus no mortal y TLR urgente hasta el Día 3.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. The study population will consist of patients with CAD undergoing PCI. Three key subgroups will be included as follows:
a. Subgroup A: Patients with ischemic symptoms at rest and positive cardiac biomarkers (troponin I or T or creatine kinase-MB) related to an acute coronary syndrome event within 7 days;
b. Subgroup B: Patients not meeting criteria for Subgroup A with at least one of the following risk factors:
? Remote acute coronary syndrome (>7 days) with positive cardiac biomarkers
? Unstable angina (ACS without positive cardiac biomarkers)
? Age >70 years
? Diabetes
? Chronic kidney disease (estimated CrCl < 60 mL/min)
? Planned multivessel PCI
? Prior CABG surgery
? Peripheral vascular disease;
c. Subgroup C: Patients with negative cardiac biomarkers and no risk factor, thereby not meeting criteria for Subgroup A or B;
2. Willing and able to sign an Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent prior to any study-related activities;
3. Male or female age 18 or greater;
4. If female of childbearing potential, must have a negative urine or serum pregnancy test or be post-menopausal for at least 1 year prior to randomization. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator?s responsibility for determining whether the patient has adequate birth control for study participation;
5. Subject is able and willing to comply with the protocol and all study procedures, including the 20 + 4 hour blood draw, Endpoint Assessment (Day 3-10) and Day 30 follow-up assessment as outlined in the protocol.

1. La población del estudio estará formada por pacientes con EC sometidos a ICP. Se incluirán tres subgrupos clave, de la siguiente manera:
a. Subgrupo A: Pacientes con síntomas isquémicos en reposo y biomarcadores cardíacos positivos (troponina I o T o creatina cinasa-MB) relacionados con un episodio de síndrome coronario agudo en los 7 días anteriores;
b. Subgrupo B: Pacientes que no cumplan los criterios para el subgrupo A y presenten al menos uno de los siguientes factores de riesgo:
? Síndrome coronario agudo remoto (> 7 días) con biomarcadores cardíacos positivos
? Angina inestable (SCA sin biomarcadores cardíacos positivos)
? Edad > 70 años
? Diabetes
? Enfermedad renal crónica (ClCr calculado de < 60 ml/min)
? ICP multivaso programada
? Cirugía previa de IDAC
? Vasculopatía periférica;
c. Subgrupo C: Pacientes con biomarcadores cardíacos negativos y sin ningún factor de riesgo, que por consiguiente no cumplan los criterios para los subgrupos A ni B;
2. Dispuestos y con capacidad para firmar, antes de cualquier actividad relacionada con el estudio, un consentimiento informado aprobado por una Junta de Revisión Institucional/un Comité Ético de Investigación Clínica (JRI/CEIC);
3. Varón o mujer que haya cumplido 18 años;
4. En el caso de una mujer en edad fértil, debe tener una prueba de embarazo en orina o en suero negativa o ser postmenopáusica durante al menos 1 año antes de la aleatorización. Las mujeres en edad fértil deben utilizar un método anticonceptivo adecuado para ser aptas. Es responsabilidad del investigador determinar si la paciente utiliza un método anticonceptivo adecuado para su participación en el estudio;
5. El paciente tiene capacidad y está dispuesto a cumplir el protocolo y todos los procedimientos del estudio, entre otros la extracción de sangre de las 20 + 4 horas, la evaluación del criterio de valoración (Día 3-10) y la evaluación de seguimiento del Día 30, tal como se describe en el protocolo.

E.4

Principal exclusion criteria

1. Acute ST-segment elevation myocardial infarction within 48 hours of randomization; of the following:
2. Evidence of current clinical instability including the following:
a. Sustained systolic blood pressure <90 mm Hg or cardiogenic shock;
b. Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade;
c. Suspected dissecting aortic aneurysm;
3. Evidence of a contraindication to anticoagulation or increased risk of bleeding such as:
a. Any evidence or history of intracranial bleeding or aneurysm;
b. Known hypercoagulable state, including treatment for malignancy (excluding basal cell skin carcinoma) in the past year, or coagulopathy with abnormal bleeding tendency;
c. History of intraocular hemorrhage other than due to diabetic retinopathy;
d. History of thrombocytopenia associated with abnormal bleeding;
e. History of thrombocytosis associated with a thrombotic event;
f. Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within 3 months;
g. Prolonged cardiopulmonary resuscitation within 3 months;
h. Major gastrointestinal bleeding within 3 months;
i. Spontaneous genitourinary bleeding within 3 months;
j. Any planned surgical procedure within 30 days after randomization;
4. Use of any investigational drug or device within 30 days of randomization or the planned use of an investigational drug or device through EOS (Day 30 follow-up);
5. Use of the following antithrombotic agents:
a. Fibrinolytic agents within 48 hours;
b. GP IIb/IIIa inhibitors within 24 hours;
c. Bivalirudin within 24 hours
d. Prior exposure to any component of REG1;
6. Baseline hemoglobin (Hgb) <9 g/dL or equivalent;
7. Renal impairment as determined by any one of the following:
a. Baseline estimated glomerular filtration rate (GFR) ? 10 mL/min/1.73m²;
b. Currently undergoing renal replacement therapy (hemodialysis or peritoneal dialysis);
c. Degree of renal impairment for which use of bivalirudin is prohibited or contraindicated per local label instructions;
8. Baseline platelet count <100,000/mm3
9. Known allergy or intolerance to aspirin, to all available ADP/P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor), or to bivalirudin or REG1 (or any of their respective components); ;
10. The following planned procedures:
a. Planned staged PCI procedure within 3 days after randomization;
b. Planned CABG or valve surgery within 30 days after randomization;
11. Any other medical or psychiatric condition that in the Investigator?s judgment precludes participation in the study.

1. Infarto de miocardio agudo con elevación del segmento ST en las 48 horas anteriores a la aleatorización;
2. Pruebas de inestabilidad clínica actual, entre otras:
a. Presión arterial sistólica sostenida < 90 mm Hg o shock cardiogénico;
b. Sospecha de miocarditis, pericarditis, endocarditis o taponamiento cardíaco agudos;
c. Sospecha de aneurisma disecante de aorta;
3. Pruebas de contraindicación de la anticoagulación o aumento de riesgo de sangrado, como por ejemplo:
a. Cualquier prueba o antecedentes de sangrado o aneurisma intracraneales;
b. Estado de hipercoagulación conocido, por ejemplo tratamiento de neoplasia maligna (excluido el carcinoma basocelular de piel) el año anterior o coagulopatía con diátesis hemorrágica anormal;
c. Antecedentes de hemorragia intraocular que no se deba a una retinopatía diabética;
d. Antecedentes de trombocitopenia asociada a un sangrado anormal;
e. Antecedentes de trombocitosis asociada a un episodio de trombosis;
f. Traumatismo importante, fractura, cirugía mayor o biopsia de un órgano parenquimatoso en los 3 meses anteriores;
g. Reanimación cardiopulmonar prolongada en los 3 meses anteriores;
h. Sangrado gastrointestinal mayor en los 3 meses anteriores;
i. Sangrado genitourinario espontáneo en los 3 meses anteriores;
j. Cualquier intervención quirúrgica programada para los 30 días posteriores a la aleatorización;
4. Uso de un fármaco o dispositivo en investigación en los 30 días anteriores a la aleatorización, o uso programado de un fármaco o dispositivo en investigación hasta el EOS (seguimiento del Día 30);
5. Uso de los siguientes agentes antitrombóticos:
a. Agentes fibrinolíticos en las 48 horas anteriores;
b. Inhibidores de GP IIb/IIIa en las 24 horas anteriores;
c. Bivalirudina en las 24 horas anteriores
d. Exposición previa a cualquiera de los componentes de REG1;
6. Hemoglobina (Hgb) inicial < 9 g/dl o equivalente;
7. Alteración renal determinada por cualquiera de los siguientes hechos:
a. Tasa de filtración glomerular (TFG) inicial calculada de ? 10 ml/min/1,73 m²;
b. Tratamiento de sustitución renal (hemodiálisis o diálisis peritoneal) actual;
c. Grado de alteración renal para el que el uso de bivalirudina esté prohibido o contraindicado de acuerdo con las instrucciones del prospecto local;
8. Recuento plaquetario inicial < 100 000/mm3;
9. Alergia o intolerancia conocidas a la aspirina, a todos los inhibidores existentes del ADP/P2Y12 (clopidogrel, prasugrel, ticagrelor), o a bivalirudina o a REG1 (o a cualquiera de sus respectivos componentes);
10. Los siguientes procedimientos quirúrgicos programados:
a. Procedimiento de ICP por etapas programada para los 3 días posteriores a la aleatorización;
b. IDAC o cirugía valvular programados para los 30 días posteriores a la aleatorización;
11. Cualquier otra circunstancia médica o psiquiátrica que a juicio del investigador impida la participación en el estudio.

E.5 End points

E.5.1

Primary end point(s)

The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3.

La combinación de muerte, infarto de miocardio no mortal, ictus no mortal y TLR urgente hasta el Día 3

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 3 -10.

Día 3 -10.

E.5.2

Secondary end point(s)

1. The composite of death, nonfatal myocardial infarction, nonfatal stroke, urgent TLR and stent thrombosis (including intra-procedural) through Day 3;
2. Major non-CABG bleeding (Bleeding Academic Research Consortium [BARC] Types 3 and 5) through Day 3;
3. The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 30;
4. The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR in Subgroup A (cardiac biomarker-positive patients) through Day 3;
5. The composite of death, nonfatal myocardial infarction, nonfatal stroke and urgent TLR in Subgroups B and C (cardiac biomarker-negative patients) through Day 3.
6. Major non-CABG bleeding (BARC Types 3 and 5) through Day 30.

Safety Endpoints
1. Incidence of bleeding (not related to CABG);
2. Incidence and severity of allergic adverse events, as well as the following:
a. Immunologic biomarker analysis;
b. Evaluations associated with risk mitigations strategies for possible allergic reactions;
3. Incidence of treatment emergent adverse events.

1. La combinación de muerte, infarto de miocardio no mortal, ictus no mortal, TLR urgente y trombosis del stent (incluida la intraoperatoria) hasta el Día 3;
2. Sangrado mayor no relacionado con IDAC (tipos 3 y 5 del Bleeding Academic Research Consortium [BARC]) hasta el Día 3;
3. La combinación de muerte, infarto de miocardio no mortal, ictus no mortal y TLR urgente hasta el Día 30;
4. La combinación de muerte, infarto de miocardio no mortal, ictus no mortal y TLR urgente en el subgrupo A (pacientes con biomarcadores cardíacos positivos) hasta el Día 3;
5. La combinación de muerte, infarto de miocardio no mortal, ictus no mortal y TLR urgente en los subgrupos B y C (pacientes con biomarcadores cardíacos negativos) hasta el Día 3;
6. Sangrado mayor no relacionado con IDAC (tipos 3 y 5 del BARC) hasta el Día 30.

Criterios de valoración de la seguridad
1. Incidencia del sangrado (no relacionado con IDAC);
2. Incidencia e intensidad de acontecimientos adversos de tipo alérgico, así como lo siguiente:
a. Análisis de biomarcadores inmunológicos;
b. Valoraciones relacionadas con estrategias de mitigación de riesgos para posibles reacciones alérgicas;
3. Incidencia de acontecimientos adversos surgidos durante el tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

Through Day 3 and Day 30.

Hasta el Día 3 y el Día 30.

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

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

Yes

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

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

203

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

Belgium

Canada

Denmark

Estonia

France

Germany

Hungary

Israel

Italy

Austria

Netherlands

Norway

Poland

Portugal

Russian Federation

Czech Republic

Slovakia

Spain

Sweden

United Kingdom

United States

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

Last call to the last patient.

Última llamada al 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

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:

6600

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

6600

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

613

F.4.2

For a multinational trial

F.4.2.1

In the EEA

8200

F.4.2.2

In the whole clinical trial

13200

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)

None

Ninguno

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

2014-01-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-01-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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