DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Cyclosporine and Prognosis in Acute Myocardial Infarction (MI) Patients

Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: ST Elevation Acute Myocardial Infarction

Intervention: Injection of Cyclosporin (Drug); Placebo (Drug); Echocardiography (Procedure)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Michel OVIZE, MD, Prof, Principal Investigator, Affiliation: Hospices Civils de Lyon

Summary

Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.

Clinical Details

Official title: Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]

Secondary outcome:

Ejection fraction

Left-Ventricular End-Diastolic Volume (LVEDV)

Left-Ventricular End-Systolic Volume (LVESV)

Time to first event [total mortality, hospitalization for heart failure]

Total mortality

Total mortality

Cardiovascular death

Cardiovascular death

Heart failure

Heart failure

Myocardial infarction

Myocardial infarction

Unstable angina

Unstable angina

Stroke

Stroke

Infarct size

Infarct size

Quality of life

Tolerance to medicinal investigational products

Predictive value of LVEDV

Infarct size: peak Troponin (T or I)

Microvascular obstruction (no reflow)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Eligibility criteria (for screening before hospital admission): 1. All (male and female) patients, aged over 18, without any legal protection measure, 2. Having a health coverage, 3. Presenting within 12 hours of the onset of chest pain, 4. Who have ST segment elevation ≥0. 2 mV in two contiguous leads, 5. For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI). And (further inclusion criteria to be confirmed by the admission coronary-angiography): 6. The culprit coronary artery has to be the LAD 7. The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography. 8. Preliminary oral informed consent followed by signed informed consent as soon as possible. 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: 1. Patients with loss of consciousness or confused 2. Patients with cardiogenic shock 3. Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region 4. Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography 5. Patients with 5. 2. known hypersensitivity to cyclosporine 5. 3. known hypersensitivity to egg, peanut or Soya-bean proteins 5. 4. known renal insufficiency (either known creatinin clearance < 30 ml/min/1. 73m² or current medical care for severe renal insufficiency) 5. 5. known liver insufficiency 5. 6. uncontrolled (treated or untreated) hypertension (> 180/110 mmHg) 6. Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine 7. Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis). 8. Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8. 2. cancer, lymphoma 8. 3. known positive serology for HIV, or hepatitis

Locations and Contacts

Algemeen Ziekenhuis Sint-Jan Brugge, Brugge 8000, Belgium

Chu Charleroi, Charleroi 6000, Belgium

Hôpital universitaire d'Anvers (UZA), Edegem 2650, Belgium

CHU Mont-Godinne, Yvoir 5530, Belgium

Clinique ESQUIROL - SAINT-HILAIRE, Agen 47000, France

Centre Hospitalier du Pays D'Aix, Aix En Provence 13616, France

Centre Hospitalier Universitaire d'Angers, Angers 49033, France

Centre Hospitalier d'Annecy, Annecy 74011, France

Hôpital Henri Duffaut, Avignon 84000, France

Clinique Lafourcade, Bayonne 64100, France

Centre Hospitalier Universitaire, Brest 29609, France

Hopital Louis Pradel, Hospices Civils de Lyon, Bron cedex 69677, France

CHRU- Hôpital de la Côte de Nacre, Caen 14033, France

Centre Hospitalier General, Chartres 28018, France

CHU - Hôpital Gabriel Montpied, Clermont Ferrand 63003, France

CH de Compiègne, Compiegne 60321, France

CH Henri MONDOR, Creteil 94010, France

Hôpital du Bocage, Dijon 21034, France

Hôpital A. MICHALLON - CHU, Grenoble 38043, France

Centre Hospitalier General, Hagueneau 67504, France

CHRU - Hôpital Cardiologique Calmette, Lille, France

Centre Hospitalier St Luc St Joseph, Lyon 69365, France

Clinique de la Sauvegarde, Lyon 69009, France

Institut Jacques Cartier, Massy 91300, France

CHU Arnaud de Villeneuve, Montpellier 34295, France

Clinique du Millénaire, Montpellier 34960, France

CHU de Mulhouse, Mulhouse 68100, France

Clinique du Diaconat, Mulhouse 69607, France

Hôpital Guillaume et René Laennec, Nantes 44093, France

CHU de Nîmes, Nimes 30029, France

Polyclinique des Fleurs, Ollioules 83192, France

APHP Hôpital Bichat, Paris 75018, France

CH de Pau, PAU 64011, France

Hôpital Haut Lévêque, Pessac 33604, France

Hôpital Claude Galien, Quincy Sous Senart 91480, France

Hôpital Pontchaillou, Rennes 35003, France

Hôpital Charles NICOLLE, Rouen 76031, France

Hôpitaux Universitaires, Nouvel Hôpital Civil, Strasbourg 67091, France

Clinique de l'Ormeau - CCV des Pyrénées, Tarbes 65000, France

CHU de Rangueil, Toulouse 31043, France

CHRU de Tours, Tours 37044, France

Clinique Saint Gatien, Tours 37042, France

Hôpital Brabois - CHU Nancy, Vandoeuvre Les Nancy 54511, France

Clinique du Tonkin, Villeurbanne 69100, France

Hospital Universitari Vall d'Hebron, Barcelona 08035, Spain

Additional Information

Starting date: April 2011
Last updated: May 20, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017