Principal Investigator Dan Gilon MD

Sponsor
Mitsubishi-Tokyo Pharmaceuticals Inc.

Monitor
Paraxel

Abstract
The study objective is to determine the safety, tolerability and effectiveness, in terms of a range of indices of myocardial function, of a single intravenous infusion of 57.5mg/48 hrs or 172.5 mg/48 hrs MCC-135 compared to placebo in patients undergoing primary PCI for AMI. The primary efficacy endpoint will be infarct size at day 7 (or discharge if sooner) as determined using resting gated SPECT. Patients are required to be randomized within 6 hours of onset of symptoms of AMI.MCC-135 infusion will be initiated as soon as possible after randomization and in any case prior to reperfusion therapy.
In a follow-up phase of the study, patients will undergo assessment of clinical signs and symptoms and adverse events at day 90 and 180.

Status
New Study