A Phase 2 interventional study of Single bolus of Placebo of CicloMulsion® (Neurovive). and Single bolus of cyclosporine A (CicloMulsion®, Neurovive) in Acute Myocardial Infarction, sponsored by Hospices Civils de Lyon. Withdrawn at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-16.
Sponsored by Hospices Civils de Lyon · Phase 2, Interventional, and Treatment
The size of the acute myocardial infarction (AMI) is related to ischemia and injury induced by tissue reperfusion. These reperfusion's injuries can be reduced by injection of cyclosporin A (CsA) at the time of reperfusion. This post-conditioning reduces the final infarct size 20 to 40%. This has been demonstrated in STEMI patients non-complicated by cardiogenic shock. Early revascularization in the AMI complicated by cardiogenic shock improves short-term and long term survival by reducing the size of the myocardial infarction. The hypothesis of this study is that the administration of Cyclosporin A to these patients, in addition to mechanical reperfusion, is likely to reduce the severity of the multi-organ failure associated with the cardiogenic shock and improve clinical outcome.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
Browse Myocardial Infarction studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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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:
Drug: Single bolus of cyclosporine A (CicloMulsion®, Neurovive)
Drug: Single bolus of Placebo of CicloMulsion® (Neurovive).
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.
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.
multiorgan failure evaluated by the SOFA score
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.
Time frame: At 24 hours after admission
multiorgan failure by SOFA score
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.
Time frame: At 48 hours after admission
multiorgan failure by SAPSII scores
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.
Time frame: At 24 hours and at 48 hours
Cardiac output (CO)
The hemodynamic changes will be estimated by measuring the cardiac output (CO) obtained by echocardiography.
Time frame: At 24 hours after inclusion
Reduction of infarct size
evaluation of the under curve area of serum creatinin kinase (CK) measured during the 72 first hours after admission (12 blood sampling).
Time frame: during the first 72 hours after admission
Reduction of cardiovascular morbidity and mortality
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.
Time frame: at 1 month
Reduction of Left ventricular remodeling
Left ventricular remodeling will be assessed at 1 month among surviving patients by measurement of left ventricular end-diastolic volume by transthoracic echocardiography
Time frame: at 1 month
This study is withdrawn, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon