drugset / Trial / NCT01650662
CYCLosporinE A in Reperfused Acute Myocardial Infarction
Phase 3
Completed
410 enrolled
Mario Negri Institute for Pharmacological Research
Heart Care Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Infarct size is a major determinant of prognosis after myocardial infarction (MI). It has been reported that Cyclosporine A (CsA) administered immediately prior to percutaneous coronary intervention (PCI) significantly could reduce reperfusion injury and consequently infarct size in ST elevation MI (STEMI) patients. CYCLE trial is a multicenter, controlled, randomized open label study, with blind assessment of endpoint measures. The objective is to determine whether a single i.v. dose of CsA within 6 hour onset of symptoms of STEMI in 444 patients, improves outcomes after successful primary PCI, by reducing myocardial injury associated to reperfusion.
Timeline
- Start
- 2012-01
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 2.5 mg/kg | Intravenous |