CClinicalTrials.gg
Status unknownNCT01245855PGEACSUpdated Nov 23, 2010

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

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

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prostaglandin E1
  • Percutaneous Coronary Intervention

Keywords

  • Prostaglandin E1
  • percutaneous coronary intervention
  • Cardiac troponin T
  • Creatine kinase-MB
03

In context

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 155 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

Interventions

  • Druglipo-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

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • First Affiliated Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01245855
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
First posted
Nov 23, 2010
Start date
Jan 2011
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Nov 23, 2010

Study contacts

Chufan Luo, Doctor
Contact
Luochufan@yahoo.com.cn
13926401972
Zhimin Du, Doctor
study director · First Affiliated Hospital, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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