Design of a trial evaluating myocardial cell protection with cariporide, an inhibitor of the transmembrane sodium-hydrogen exchanger: the Guard During Ischemia Against Necrosis (GUARDIAN) trial.

Inhibition of the sodium-hydrogen exchanger (NHE) is a powerful experimental tool to inhibit sodium and calcium accumulation within the ischemic myocyte and halt progression of cell ischemia to cell necrosis. This paper describes the protocol and rationale of a first large-scale clinical trial designed to evaluate the safety and efficacy of cariporide, a novel specific and potent inhibitor of the exchanger.