NCT01245855

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 23, 2010

Status Verified

October 1, 2010

Enrollment Period

11 months

First QC Date

November 22, 2010

Last Update Submit

November 22, 2010

Conditions

Prostaglandin E1Percutaneous Coronary Intervention

Keywords

Prostaglandin E1percutaneous coronary interventionCardiac troponin TCreatine kinase-MB

Outcome Measures

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

    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

    2 years

Study Arms (1)

PGE1 group and control group

NO INTERVENTION

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

lipo-PGE1DRUG

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
PGE1 group and control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Cardiomyopathy, Familial Restrictive, 3

Interventions

Alprostadil

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsFatty Acids, MonounsaturatedAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Zhimin Du, Doctor

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY DIRECTOR

Central Study Contacts

Chufan Luo, Doctor

CONTACT

13926401972Luochufan@yahoo.com.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 23, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 23, 2010

Record last verified: 2010-10

Locations

CN(1)