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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00091637




Registration number
NCT00091637
Ethics application status
Date submitted
14/09/2004
Date registered
16/09/2004
Date last updated
18/11/2023

Titles & IDs
Public title
Pexelizumab in Conjunction With Angioplasty in Acute Myocardial Infarction (APEX-AMI)
Scientific title
APEX-AMI - Pexelizumab in Conjunction With Angioplasty
Secondary ID [1] 0 0
2003056
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myocardial Infarction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pexelizumab
Treatment: Drugs - Placebo infusion

Placebo comparator: 1 - Placebo infusion

Experimental: 2 - Pexelizumab infusion


Treatment: Drugs: Pexelizumab
Pexelizumab (2 mg/kg) intravenous , bolus for 10 minutes once

Treatment: Drugs: Placebo infusion
bolus infusion over a 10 minute period once
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction of all causes of mortality
Timepoint [1] 0 0
day 30

Eligibility
Key inclusion criteria
* Cardiac symptoms for at least 20 minutes within past 6 hours;
* Will undergo primary PCI;
* Has ECG evidence of acute high risk ST elevation myocardial infarction;
* Willing and able to be followed for at least 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Isolated low risk inferior wall myocardial infarction;
* Received fibrinolytic therapy;
* History of complement deficiency;
* Suspected neisserial infection;
* Participating in other investigational study;
* Pregnancy;
* Previous enrollment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2007
Sample size
Target
Accrual to date
Final
5745
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
St. George Hospital - Kogarah
Recruitment hospital [5] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [7] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [8] 0 0
Prince Charles Hospital - Chermside
Recruitment hospital [9] 0 0
Townsville Hospital - Douglas
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Wooloong Abba
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [12] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [13] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [14] 0 0
Austin Hospital - Box Hill
Recruitment hospital [15] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [16] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [17] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [18] 0 0
Victorian Heart Clinic - Richmond
Recruitment hospital [19] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [20] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [21] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2137 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
2031 - Randwick
Recruitment postcode(s) [7] 0 0
2065 - St. Leonards
Recruitment postcode(s) [8] 0 0
4032 - Chermside
Recruitment postcode(s) [9] 0 0
4814 - Douglas
Recruitment postcode(s) [10] 0 0
4102 - Wooloong Abba
Recruitment postcode(s) [11] 0 0
5000 - Adelaide
Recruitment postcode(s) [12] 0 0
5042 - Bedford Park
Recruitment postcode(s) [13] 0 0
5011 - Woodville South
Recruitment postcode(s) [14] 0 0
3084 - Box Hill
Recruitment postcode(s) [15] 0 0
3128 - Box Hill
Recruitment postcode(s) [16] 0 0
3162 - Clayton
Recruitment postcode(s) [17] 0 0
3050 - Parkville
Recruitment postcode(s) [18] 0 0
3121 - Richmond
Recruitment postcode(s) [19] 0 0
6160 - Fremantle
Recruitment postcode(s) [20] 0 0
6009 - Nedlands
Recruitment postcode(s) [21] 0 0
6000 - Perth
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Procter and Gamble
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Thomas G Todaro, MD, JD, FACC
Address 0 0
Procter and Gamble
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00091637