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Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention (PGEACS)

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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
Sponsor:
Information provided by:
First Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
we hypothesized that periprocedural treatment with intravenous lipo-PGE1 may reduce myocardial injury and improve clinical outcomes in patients undergoing PCI.

Condition or disease Intervention/treatment Phase
Prostaglandin E1 Percutaneous Coronary Intervention Drug: lipo-PGE1 Phase 3

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil
U.S. FDA Resources

Arm Intervention/treatment
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
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
Other Name: Prostaglandin E1 incorporated in lipid microspheres



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • the presence of a non-ST-segment elevation acute coronary syndrome (unstable angina or non-ST-segment elevation acute myocardial infarction) sent to early PCI (within 72h of the onset of symptoms)

Exclusion Criteria:

  • a ST-segment elevation acute myocardial infarction, non-ST-segment elevation acute coronary syndrome with high-risk features warranting emergency invasive approach, left ventricular ejection fraction <35%, previous revascularization, or renal failure with creatinine >3 mg/dl

Information from the National Library of Medicine

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


Contacts
Contact: Chufan Luo, Doctor 13926401972 Luochufan@yahoo.com.cn

Locations
China, Guangdong
First Affiliated Hospital, Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Chufan Luo, Doctor    13926401972    Luochufan@yahoo.com.cn   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Director: Zhimin Du, Doctor First Affiliated Hospital, Sun Yat-Sen University

Responsible Party: Luo Chufan, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01245855     History of Changes
Other Study ID Numbers: PGEACS
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: October 2010

Keywords provided by First Affiliated Hospital, Sun Yat-Sen University:
Prostaglandin E1
percutaneous coronary intervention
Cardiac troponin T
Creatine kinase-MB

Additional relevant MeSH terms:
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents