CYCLosporinE A in Reperfused Acute Myocardial Infarction

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborator: Heart Care Foundation
• Treatments: Cyclosporine; Cyclosporins

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