Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000238572
Ethics application status
Approved
Date submitted
7/06/2006
Date registered
14/06/2006
Date last updated
14/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
ERYTHROPOIETIN STUDY
Scientific title
Feasibility and safety of erythropoietin (EPO) administration in patients with acute myocardial infarction (AMI) to improve cardiac function and remodelling.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction (AMI) 1215 0
Condition category
Condition code
Cardiovascular 1300 1300 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Erythropoietin administration (10000units given as a one-off [single dose] intravenous bolus dose) within 24 hours of primary percutaneous intervention to treat patients with AMI. As this is a phase I safety study all subjects will receive open-label erythropoietin and there will be no control group or comparitor.
Intervention code [1] 1130 0
Treatment: Drugs
Comparator / control treatment
No control group or comparitor.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1775 0
1. all cause mortality
Timepoint [1] 1775 0
At 6 months
Primary outcome [2] 1776 0
2. hyperviscosity events (stent thrombosis, stroke, AMI or heart failure in the setting of a concomitant high haematocrit)
Timepoint [2] 1776 0
At 6 months
Secondary outcome [1] 3129 0
1. Left ventricular ejection fraction
Timepoint [1] 3129 0
At 6 months
Secondary outcome [2] 3130 0
2. Readmission for cardiac failure
Timepoint [2] 3130 0
Over 6 months
Secondary outcome [3] 3131 0
3. Target vessel revascularisation
Timepoint [3] 3131 0
Over 6 months
Secondary outcome [4] 3132 0
4. Change in New York Heart Association functional class
Timepoint [4] 3132 0
Over 6 months (assessed at baseline, 30, 90 and 180 days).

Eligibility
Key inclusion criteria
Acute ST elevation myocardial infarction that are treated with primary angioplasty and stenting who have significant left ventricular (LV) impairment.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple - but particularly major comorbidities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1426 0
Commercial sector/Industry
Name [1] 1426 0
Eastern Heart Clinic
Country [1] 1426 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Eastern Heart Clinic
Address
Country
Australia
Secondary sponsor category [1] 1254 0
None
Name [1] 1254 0
nil
Address [1] 1254 0
Country [1] 1254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2800 0
Prince of Wales Hospital
Ethics committee address [1] 2800 0
Ethics committee country [1] 2800 0
Australia
Date submitted for ethics approval [1] 2800 0
Approval date [1] 2800 0
Ethics approval number [1] 2800 0
Ethics committee name [2] 2801 0
Sutherland Hospital
Ethics committee address [2] 2801 0
Ethics committee country [2] 2801 0
Australia
Date submitted for ethics approval [2] 2801 0
Approval date [2] 2801 0
Ethics approval number [2] 2801 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35350 0
Address 35350 0
Country 35350 0
Phone 35350 0
Fax 35350 0
Email 35350 0
Contact person for public queries
Name 10319 0
Dr. Eugene Loh
Address 10319 0
Cardiology Department
Prince of Wales Hospital
Barker St
Randwick 2031
Country 10319 0
Australia
Phone 10319 0
61 2 93821111
Fax 10319 0
Email 10319 0
[email protected]
Contact person for scientific queries
Name 1247 0
Dr. Eugene Loh
Address 1247 0
Cardiology Department
Prince of Wales Hospital
Barker St
Randwick 2031
Country 1247 0
Australia
Phone 1247 0
61 2 93821111
Fax 1247 0
Email 1247 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.