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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01245855
First received: November 22, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Prostaglandin E1
Percutaneous Coronary Intervention
Drug: lipo-PGE1
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Protective Effect of Lipo-PGE1 on Myocardial Injury Following Percutaneous Coronary Intervention

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Luo Chufan, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01245855     History of Changes
Other Study ID Numbers: PGEACS
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: SFDA:China

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:
Wounds and Injuries
Alprostadil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Urological Agents

ClinicalTrials.gov processed this record on September 14, 2014