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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00091637
Ethics application status
Date submitted
14/09/2004
Date registered
16/09/2004
Date last updated
5/08/2011

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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
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Concord Hospital - Concord
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Gosford Hospital - Gosford
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St. George Hospital - Kogarah
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Liverpool Hospital - Liverpool
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Prince of Wales Hospital - Randwick
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Royal North Shore Hospital - St. Leonards
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Prince Charles Hospital - Chermside
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Townsville Hospital - Douglas
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Wooloong Abba
Recruitment hospital [11] 0 0
Royal Adelaide Hospital - Adelaide
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Flinders Medical Centre - Bedford Park
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The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [14] 0 0
Austin Hospital - Box Hill
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Box Hill Hospital - Box Hill
Recruitment hospital [16] 0 0
Monash Medical Centre - Clayton
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Royal Melbourne Hospital - Parkville
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Victorian Heart Clinic - Richmond
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Fremantle Hospital - Fremantle
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Sir Charles Gairdner Hospital - Nedlands
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Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2137 - Concord
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2250 - Gosford
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2217 - Kogarah
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2170 - Liverpool
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2031 - Randwick
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2065 - St. Leonards
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4032 - Chermside
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4814 - Douglas
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4102 - Wooloong Abba
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5000 - Adelaide
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5042 - Bedford Park
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5011 - Woodville South
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3084 - Box Hill
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3128 - Box Hill
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3162 - Clayton
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3050 - Parkville
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3121 - Richmond
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6160 - Fremantle
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6009 - Nedlands
Recruitment postcode(s) [21] 0 0
6000 - Perth
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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
In the setting of reperfusion therapy in an acute myocardial infarction using primary
percutaneous intervention (PCI), the body's own inflammatory system involving the complement
cascade may be harmful. This study will test the safety and efficacy of a novel complement
inhibitor, pexelizumab to reduce mortality at 30 days.
Trial website
https://clinicaltrials.gov/show/NCT00091637
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

Summary results
Other publications