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CYCLosporinE A in Reperfused Acute Myocardial Infarction

NCT01650662 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2015-04-16

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

Cyclosporine A

In the CsA group, at least 5 min before balloon inflation and stenting, patients will receive an intravenous bolus injection of 2.5 mg/kg of CsA. In the control group, patients will receive only recommended treatments. CsA will be dissolved in normal NaCl 0.9% solution (final concentration 25 mg/ml) and injected slowly (over 20-30 seconds) via a catheter positioned in an antecubital vein at least 5 min before PCI, to allow for distribution of the drug.

Sponsors & Collaborators

  • Heart Care Foundation

    collaborator OTHER

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Roberto Latini, MD · Mario Negri Institute, Milan, Italy

  • Filippo Ottani, MD · Ospedale G.B. Morgagni, Pierantoni, Forlì, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01650662 on ClinicalTrials.gov