Clinical trial NCT01901471: Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Official title: Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Keywords: Cyclosporine, cardiogenic shock, SOFA score,
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: multiorgan failure evaluated by the SOFA score
timeFrame: At 24 hours after admission
Secondary outcomes:
measure: multiorgan failure by SOFA score
timeFrame: At 48 hours after admission
measure: multiorgan failure by SAPSII scores
timeFrame: At 24 hours and at 48 hours
measure: Cardiac output (CO)
timeFrame: At 24 hours after inclusion
measure: Reduction of infarct size
timeFrame: during the first 72 hours after admission
measure: Reduction of cardiovascular morbidity and mortality
timeFrame: at 1 month
measure: Reduction of Left ventricular remodeling
timeFrame: at 1 month
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: CH Pays d'Aix
city: Bayonne
country: France
facility: Clinique de La Fourcade
city: Bron
country: France
facility: CHU Hopital Cardiologique Louis Pradel
city: Clermont-ferrand
country: France
facility: Hôpital Gabriel Montpied
city: Dijon
country: France
facility: Chu Hopital Du Bocage
city: Grenoble
country: France
facility: Chu Hopital A Michallon
city: Lyon
country: France
facility: Hopital St Luc St Joseph
city: Montpellier
country: France
facility: Chu Arnaud de Villeneuve
city: Nantes
country: France
facility: Hopital Guillaume Et Rene Laennec
city: Nimes
country: France
facility: Chu de Nimes
city: Paris
country: France
facility: Aphp Hopital Bichat
city: PAU
country: France
facility: Centre Hospitalier de Pau
city: Pessac
country: France
facility: Chu de Bordeaux
city: Rouen
country: France
facility: Hopital Charles Nicolle
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Toulouse
country: France
facility: Chu de Rangueil
city: Tours
country: France
facility: Chru de Tours
city: Vandoeuvre Les Nancy
country: France
facility: Chu de Nancy Brabois
Study officials:
affiliation: CHU-Hôpital Cardiologique Louis Pradel BRON
name: Eric Bonnefoy-Cudraz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: