NCT01901471

Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
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.
DRUG	Single bolus of cyclosporine A (CicloMulsion®, Neurovive)	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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2013-07-17
• Last updated: 2016-03-16

Locations

18 sites across 1 country: France