Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention (PGEACS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01245855|
Recruitment Status : Unknown
Verified October 2010 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Not yet recruiting
First Posted : November 23, 2010
Last Update Posted : November 23, 2010
|Condition or disease||Intervention/treatment||Phase|
|Prostaglandin E1 Percutaneous Coronary Intervention||Drug: lipo-PGE1||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
No Intervention: PGE1 group and control group
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
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
Other Name: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245855
|Contact: Chufan Luo, Doctor||13926401972||Luochufan@yahoo.com.cn|
|First Affiliated Hospital, Sun Yat-sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Chufan Luo, Doctor 13926401972 Luochufan@yahoo.com.cn|
|Study Director:||Zhimin Du, Doctor||First Affiliated Hospital, Sun Yat-Sen University|