PROTECTION AMI (Inhibition of δ-PROTEin kinase C for the reducTION of infarct size in Acute Myocardial Infarction) is a Phase 2b, randomized, placebo-controlled, single-dose, parallel group, multinational trial. It will enroll 1,058 subjects with ST segment elevation myocardial infarction (STEMI) undergoing acute reperfusion therapy by percutaneous coronary intervention (PCI). Subjects with STEMI will randomly receive one of three doses of KAI-9803 or placebo by IV infusion prior to PCI. Infarct size is the primary efficacy endpoint, and safety and assessments of microvascular perfusion and cardiac function by MUGA are secondary measures. KAI-9803 is an isozyme-selective inhibitor of the delta (δ) protein kinase C pathway and aims to reduce the size of the MI and improve clinical outcomes.

A. Michael Lincoff, MD, is the national PI.  C5Research is coordinating the academic leadership and providing event adjudication (CEC) and MUGA Core Labs.  KAI Pharmaceuticals is the sponsor in partnership with Bristol-Myers Squibb.