- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01901471
Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock (CLOTILDE)
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Aix-en-Provence, Francia, 13616
- Ch Pays D'Aix
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Bayonne, Francia, 64100
- Clinique de La Fourcade
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Bron, Francia, 69677
- CHU Hopital Cardiologique Louis Pradel
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Clermont-ferrand, Francia, 63003
- Hopital Gabriel Montpied
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Dijon, Francia, 21034
- CHU Hôpital du Bocage
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Grenoble, Francia, 38043
- Chu Hopital A Michallon
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Lyon, Francia
- Hopital St Luc St Joseph
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Montpellier, Francia, 34295
- CHU Arnaud de Villeneuve
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Nantes, Francia, 44093
- Hopital Guillaume Et Rene Laennec
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Nimes, Francia, 30029
- CHU de Nimes
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PAU, Francia, 64011
- Centre Hospitalier de Pau
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Paris, Francia, 75018
- APHP Hôpital Bichat
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Pessac, Francia, 33604
- CHU de Bordeaux
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Rouen, Francia, 76031
- Hopital Charles Nicolle
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Strasbourg, Francia, 67091
- Nouvel Hopital Civil
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Toulouse, Francia, 31403
- CHU de Rangueil
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Tours, Francia, 37044
- CHRU de Tours
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Vandoeuvre Les Nancy, Francia, 54511
- CHU de Nancy Brabois
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients ( male or female), aged over 18, without any legal protection measure
- Having a health coverage
- Presenting within 12 hours of the onset of chest pain, with a ST segment elevation or non ST elevation and for whom the clinical decision was made to treat with percutaneous coronary intervention (PCI) primary or rescue
- Occlusion of culprit coronary artery (TIMI flow grade = 0 or 1) at the time of admission in the catheterism laboratory
- Patient presenting a cardiogenic shock defined by a SBP<90mmhg for a period over 30 minutes and do not answering to a test of vascular charge associated with signs peripheral hypoperfusion (cold extremities, cyanosis, oliguria with urine output <50 ml/h or alteration of higher mental functions).
- Clear information is delivered to the patient or a legal representative if present and preliminary oral consent obtained, followed by obtaining written consent signed as soon as possible, in accordance with ICH.
NB: Patients undergoing either primary PCI or rescue PCI are eligible for the study.
Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.
Exclusion Criteria:
- TIMI flow grade >1
- Patients in cardiac arrest
- Patients with mechanical complication of myocardial infarction at admission (septal, broken pillar cracking or myocardial rupture, tamponade).
- Patients with other causes of hemodynamic shock: hemorrhagic, septic or anaphylactic.
- Patients with known hypersensitivity to cyclosporine, hypersensitivity to egg, peanut or Soya-bean proteins
- Renal insufficiency (either known creatinine clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
- Patients treated with any compound containing Hypericum perforatum (St. John's Wort) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
- Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
- Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation, cancer, lymphoma, known positive serology for HIV, or hepatitis
- Participation to another clinical trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: CsA Group
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The investigational medicinal product is cyclosporine A (CicloMulsion®, Neurovive). Cyclosporine A is an immunosuppressive treatment usually used in the prevention of acute rejection after organ transplant, including cardiac transplantation. Usual dosages in organ transplantation are about 2.5 mg / kg per day in 2 doses. CicloMulsion® is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution. Production blinded labelling, packaging and delivering the study drugs in every participating centre of the trial will be performed by a company following European Union's Good Manufacturing Practice. CicloMulsion® 5mg/ml is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml. The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes. |
Comparador de placebos: Grupo placebo
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The matching placebo of CicloMulsion® (Neurovive) is composed with refined Soya-bean oil, medium-chain triglycerides, egg lecithin, water-free glycerol, sodium oleate, sodium hydroxide, water injection. The qualitative composition of CicloMulsion® and its placebo only differ in the presence or absence of Cyclosporine A, so the final emulsions will be visually indistinguishable. The placebo use here is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution. The placebo is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml. The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
multiorgan failure evaluated by the SOFA score
Periodo de tiempo: At 24 hours after admission
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The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal, neurological and the biological parameters of coagulation of the patient.
This score is spread from 0 to 24 points.
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At 24 hours after admission
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
multiorgan failure by SOFA score
Periodo de tiempo: At 48 hours after admission
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The SOFA clinico-biological score takes into account the respiratory status, cardiac, hepatic, renal,neurological and the biological parameters of coagulation of the patient.
This score is spread from 0 to 24 points.
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At 48 hours after admission
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multiorgan failure by SAPSII scores
Periodo de tiempo: At 24 hours and at 48 hours
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The SAPSII score takes into account the hemodynamic, clinical, biological status of the patient.
The parameters are : history of patient (type of admission, chronic disease, age), clinical parameters as systolic pressure measurement, heart rate, temperature, urine output of 24 hours and biological parameters as measurement of blood count white, serum total bilirubin, serum urea, serum sodium, serum potassium and bicarbonate level serum.
pressure measurement arterial oxygen in arterial blood gases.
This score is spread from 0 to 163 points.
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At 24 hours and at 48 hours
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Cardiac output (CO)
Periodo de tiempo: At 24 hours after inclusion
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The hemodynamic changes will be estimated by measuring the cardiac output (CO) obtained by echocardiography.
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At 24 hours after inclusion
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Reduction of infarct size
Periodo de tiempo: during the first 72 hours after admission
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evaluation of the under curve area of serum creatinin kinase (CK) measured during the 72 first hours after admission (12 blood sampling).
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during the first 72 hours after admission
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Reduction of cardiovascular morbidity and mortality
Periodo de tiempo: at 1 month
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The incidence that occurred in one month (D30) of the following clinical criteria will be collected: death, ventricular fibrillation or ventricular tachycardia requiring electrical cardioversion, placed under mechanical cardiac support (other than against drive-by intra-aortic balloon) , reinfarction, hospitalization for heart failure.
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at 1 month
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Reduction of Left ventricular remodeling
Periodo de tiempo: at 1 month
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Left ventricular remodeling will be assessed at 1 month among surviving patients by measurement of left ventricular end-diastolic volume by transthoracic echocardiography
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at 1 month
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eric Bonnefoy-Cudraz, MD, PhD, CHU-Hôpital Cardiologique Louis Pradel BRON
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Isquemia
- Procesos Patológicos
- Necrosis
- Isquemia miocardica
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Choque
- Infarto de miocardio
- Infarto
- Choque Cardiogénico
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiinfecciosos
- Inhibidores de enzimas
- Agentes antirreumáticos
- Agentes inmunosupresores
- Factores inmunológicos
- Agentes dermatológicos
- Agentes antifúngicos
- Inhibidores de calcineurina
- Ciclosporina
- Ciclosporinas
Otros números de identificación del estudio
- 2012.754
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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