Percutaneous Coronary Intervention Clinical Trial
Official title:
Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention
we hypothesized that periprocedural treatment with intravenous lipo-PGE1 may reduce myocardial injury and improve clinical outcomes in patients undergoing PCI.
Ever since the inception of percutaneous coronary intervention (PCI), it has been apparent
that some myocardial injury was often associated with the procedure, and even asymptomatic
minor post-procedural myocardial necrosis does have an important prognostic signification.
The possible mechanisms of periprocedural myocardial injury were often attributed to distal
embolisation of atheromatous material during the procedure, occlusion of minute side
branches, occlusive dissection or no-reflow.
Prostaglandin E1 incorporated in lipid microspheres (lipo-PGE1) is a new galenic form of
PGE1, with PGE1 incorporated into soybean oil microspheres 0.2 micron in diameter, using
lecithin as surfactant. This drug preparation can protect PGE1 against inactivation in the
lung and has targeting effect to tissues injured by arterial occlusion. It was shown in the
experiments that, by the pharmacological effects such as improving endothelial function,
dilating coronary and systemic microvessels, inhibiting platelet aggregation and reducing
ischemia-reperfusion injury, lipo-PGE1 had a more marked protective effect in arterial
occlusive tissue injury and a more potent platelet aggregation inhibitory effect than free
PGE1. Clinical studies have demonstrated that lipo-PGE1 is a very valuable agent for the
treatment of peripheral vascular disorders and diabetic neuropathy.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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