CYCLosporinE A in Reperfused Acute Myocardial Infarction (CYCLE)
Acute Myocardial Infarction
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction, Cyclosporine A, Reperfusion, Clinical Trial
Eligibility Criteria
Inclusion Criteria:
- Male and female patients with large STEMI not older than 6 hours, defined as
- angina pectoris or equivalent symptoms of more than 20 minutes duration within last 6 hours, and
- ST elevation in at least 3 leads in anterior MI and/or a deviation in at least 4 leads in inferior MI,
- TIMI flow 0 or 1 in identified culprit artery
- Intended acute primary PCI
- Age ≥ 18 years
- Ability to understand the nature, scope, and possible consequences of the study participation/legal capacity
- Written informed consent
Exclusion Criteria:
- Left bundle branch block
- TIMI flow > 1 in the identified culprit artery
- Treatment with CsA within last 10 days
- Contraindication to CsA or history of allergic reaction to CsA
- Coronary anatomy not suitable for PCI
- Thrombolytic therapy within 24 h. before randomization
- Previous MI
- Previous CABG
- Severe renal or hepatic insufficiency
- Malignant tumor, not curatively treated
- Women with childbearing potential, esp. pregnant or nursing women
- Participation in another clinical or device trial within the previous 30 days
Sites / Locations
- Ospedale Regionale Umberto Parini
- Ospedale S. Donato
- Ospedale San Paolo
- Azienda Ospedaliera di Seriate
- Azienda Ospedaliera di Treviglio
- Policlinico S.Marco
- Ospedale Maggiore
- Istituto Fondazione Poliambulanza
- Azienda Ospedaliera G.Brotzu
- Azienda Ospedaliera Santa Croce e Carle
- Ospedale delle Misericordie
- Ospedale Campo di Marte
- Ospedale di Desio
- Policlinico Monza
- AOR Villa Sofia - Cervello P.O.
- AOR Villa Sofia - Cervello PO Villa Sofia
- Ospedale Civile dello Spirito Santo
- Ospedale Santa Maria delle Croci
- Ospedale San Camillo
- Ospedale Infermi
- Ospedale Santa Corona
- Ospedale Santa Chiara
- Ospedale degli Infermi
- Ospedale Maria Vittoria
- Azienda Ospedaliera Universitaria - Ospedale Riuniti
- Ospedale S. Giacomo
- Ospedale Ca' Foncello
- Azienda Ospedaliera -Univ. S. Maria delle Misericordie
- Ospedale dell'Angelo
- Ospedale Civile San Bortolo
- Ospedale G.B. Morgani - L. Pierantoni
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cyclosporine A
Control group
The investigational active treatment is CsA, an immunosuppressant indicated for the prevention of acute rejection after organ transplant, including cardiac transplantation. The preparation used in the trial will be Sandimmun IV, containing CsA 50 mg/ml, Cremophor® EL and 94% ethyl alcohol in a 5 ml vial. Patients will received Cyclosporine A on the top of recommended standard care for acute myocardial infarction.
The control group received on the top of recommended standard care for acute myocardial infarction.