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

NCT ID: NCT01245855

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostaglandin E1 Percutaneous Coronary Intervention

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

lipo-PGE1

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Prostaglandin E1 incorporated in lipid microspheres

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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First Affiliated Hospital, Sun Yat-Sen University

Principal Investigators

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Zhimin Du, Doctor

Role: STUDY_DIRECTOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Chufan Luo, Doctor

Role: CONTACT

Phone: 13926401972

Email: [email protected]

Facility Contacts

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Chufan Luo, Doctor

Role: primary

Other Identifiers

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PGEACS

Identifier Type: -

Identifier Source: org_study_id