A Phase 3 interventional study of lipo-PGE1 in Prostaglandin E1 and Percutaneous Coronary Intervention, sponsored by First Affiliated Hospital, Sun Yat-Sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-11-23.
Sponsored by First Affiliated Hospital, Sun Yat-Sen University · Phase 3, Interventional, and Treatment
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.
First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
the control group: received only the conventional medications, the PGE1 group: received additional 20 micrograms/day of lipo-PGE1 intravenously, starting at least 24 hours before PCI and continuing for 5 days
Drug: lipo-PGE1
those in the PGE1 group received additional 20 micrograms/day of lipo-PGE1 intravenously, starting at least 24 hours before PCI and continuing for 5 days
Also known as: Prostaglandin E1 incorporated in lipid microspheres
The primary objective of the present study is to assess the effects of lipo-PGE1 on postprocedural changes of cardiac biomarker levels in patients with non-ST-segment elevation ACS following hospital admission for early PCI
Time frame: 2 years
The secondary objectives are to evaluate the efficacy of lipo-PGE1 in improving cardiovascular outcomes, and the safety and tolerability profile of lipo-PGE1
Time frame: 2 years
This study is status unknown, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital, Sun Yat-Sen University