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

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

Study Overview

• Status: Unknown
• Conditions: Percutaneous Coronary Intervention; Prostaglandin E1
• Intervention / Treatment: Drug: lipo-PGE1

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
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • First Affiliated Hospital, Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Prostaglandin E1 incorporated in lipid microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary objectives are to evaluate the efficacy of lipo-PGE1 in improving cardiovascular outcomes, and the safety and tolerability profile of lipo-PGE1	2 years

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: Zhimin Du, Doctor, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2011
• Study Completion (ANTICIPATED): December 1, 2011

Study Registration Dates

• First Submitted: November 22, 2010
• First Submitted That Met QC Criteria: November 22, 2010
• First Posted (ESTIMATE): November 23, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 23, 2010
• Last Update Submitted That Met QC Criteria: November 22, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; Prostaglandin E1; Cardiac troponin T; Creatine kinase-MB
• Additional Relevant MeSH Terms: Vasodilator Agents; Urological Agents; Platelet Aggregation Inhibitors; Alprostadil
• Other Study ID Numbers: PGEACS