Overview

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