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Cyclosporine in Acute Myocardial Infarction Complicated by Cardiogenic Shock (CLOTILDE)

15 mars 2016 uppdaterad av: Hospices Civils de Lyon
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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Aix-en-Provence, Frankrike, 13616
        • CH Pays d'Aix
      • Bayonne, Frankrike, 64100
        • Clinique de La Fourcade
      • Bron, Frankrike, 69677
        • CHU Hopital Cardiologique Louis Pradel
      • Clermont-ferrand, Frankrike, 63003
        • Hôpital Gabriel Montpied
      • Dijon, Frankrike, 21034
        • CHU Hopital du Bocage
      • Grenoble, Frankrike, 38043
        • Chu Hopital A Michallon
      • Lyon, Frankrike
        • Hopital St Luc St Joseph
      • Montpellier, Frankrike, 34295
        • CHU Arnaud de Villeneuve
      • Nantes, Frankrike, 44093
        • Hopital Guillaume Et Rene Laennec
      • Nimes, Frankrike, 30029
        • CHU de Nîmes
      • PAU, Frankrike, 64011
        • Centre Hospitalier de Pau
      • Paris, Frankrike, 75018
        • APHP Hôpital Bichat
      • Pessac, Frankrike, 33604
        • CHU de Bordeaux
      • Rouen, Frankrike, 76031
        • Hôpital Charles Nicolle
      • Strasbourg, Frankrike, 67091
        • Nouvel hopital civil
      • Toulouse, Frankrike, 31403
        • CHU de Rangueil
      • Tours, Frankrike, 37044
        • CHRU de Tours
      • Vandoeuvre Les Nancy, Frankrike, 54511
        • CHU de Nancy Brabois

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: CsA Group
Läkemedel: 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.
Placebo-jämförare: Placebogrupp
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
multiorgan failure evaluated by the SOFA score
Tidsram: At 24 hours after admission
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.
At 24 hours after admission

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
multiorgan failure by SOFA score
Tidsram: At 48 hours after admission
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.
At 48 hours after admission
multiorgan failure by SAPSII scores
Tidsram: At 24 hours and at 48 hours
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.
At 24 hours and at 48 hours
Cardiac output (CO)
Tidsram: At 24 hours after inclusion
The hemodynamic changes will be estimated by measuring the cardiac output (CO) obtained by echocardiography.
At 24 hours after inclusion
Reduction of infarct size
Tidsram: during the first 72 hours after admission
evaluation of the under curve area of serum creatinin kinase (CK) measured during the 72 first hours after admission (12 blood sampling).
during the first 72 hours after admission
Reduction of cardiovascular morbidity and mortality
Tidsram: at 1 month
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.
at 1 month
Reduction of Left ventricular remodeling
Tidsram: at 1 month
Left ventricular remodeling will be assessed at 1 month among surviving patients by measurement of left ventricular end-diastolic volume by transthoracic echocardiography
at 1 month

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hospices Civils de Lyon

Utredare

  • Huvudutredare: Eric Bonnefoy-Cudraz, MD, PhD, CHU-Hôpital Cardiologique Louis Pradel BRON

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 september 2015

Primärt slutförande (Förväntat)

1 oktober 2015

Avslutad studie (Förväntat)

1 oktober 2015

Studieregistreringsdatum

Först inskickad

11 juli 2013

Först inskickad som uppfyllde QC-kriterierna

15 juli 2013

Första postat (Uppskatta)

17 juli 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 mars 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 mars 2016

Senast verifierad

1 mars 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2012.754

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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