Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Iowa
Country [13] 0 0
United States of America
State/province [13] 0 0
Kansas
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Louisiana
Country [16] 0 0
United States of America
State/province [16] 0 0
Maine
Country [17] 0 0
United States of America
State/province [17] 0 0
Maryland
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
Nevada
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
United States of America
State/province [25] 0 0
New Mexico
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
North Dakota
Country [29] 0 0
United States of America
State/province [29] 0 0
Ohio
Country [30] 0 0
United States of America
State/province [30] 0 0
Oklahoma
Country [31] 0 0
United States of America
State/province [31] 0 0
Oregon
Country [32] 0 0
United States of America
State/province [32] 0 0
Pennsylvania
Country [33] 0 0
United States of America
State/province [33] 0 0
Rhode Island
Country [34] 0 0
United States of America
State/province [34] 0 0
South Carolina
Country [35] 0 0
United States of America
State/province [35] 0 0
South Dakota
Country [36] 0 0
United States of America
State/province [36] 0 0
Tennessee
Country [37] 0 0
United States of America
State/province [37] 0 0
Texas
Country [38] 0 0
United States of America
State/province [38] 0 0
Utah
Country [39] 0 0
United States of America
State/province [39] 0 0
Virginia
Country [40] 0 0
United States of America
State/province [40] 0 0
Washington
Country [41] 0 0
United States of America
State/province [41] 0 0
West Virginia
Country [42] 0 0
United States of America
State/province [42] 0 0
Wisconsin
Country [43] 0 0
Austria
State/province [43] 0 0
Linz
Country [44] 0 0
Austria
State/province [44] 0 0
Wien
Country [45] 0 0
Belgium
State/province [45] 0 0
Brabant
Country [46] 0 0
Belgium
State/province [46] 0 0
Limburg
Country [47] 0 0
Belgium
State/province [47] 0 0
Vlaanderen
Country [48] 0 0
Belgium
State/province [48] 0 0
Antwerpen
Country [49] 0 0
Belgium
State/province [49] 0 0
Liege
Country [50] 0 0
Canada
State/province [50] 0 0
Alberta
Country [51] 0 0
Canada
State/province [51] 0 0
British Columbia
Country [52] 0 0
Canada
State/province [52] 0 0
New Brunswick
Country [53] 0 0
Canada
State/province [53] 0 0
Newfoundland and Labrador
Country [54] 0 0
Canada
State/province [54] 0 0
Ontario
Country [55] 0 0
Canada
State/province [55] 0 0
Quebec
Country [56] 0 0
Canada
State/province [56] 0 0
Saskatchewan
Country [57] 0 0
Czechia
State/province [57] 0 0
Ceske Budejovice
Country [58] 0 0
Czechia
State/province [58] 0 0
Hradec Kralove
Country [59] 0 0
Czechia
State/province [59] 0 0
Prague
Country [60] 0 0
Czechia
State/province [60] 0 0
Usti Nad Labem
Country [61] 0 0
Czechia
State/province [61] 0 0
Brno
Country [62] 0 0
Czechia
State/province [62] 0 0
Liberec
Country [63] 0 0
Czechia
State/province [63] 0 0
Olomouc
Country [64] 0 0
Czechia
State/province [64] 0 0
Ostrava
Country [65] 0 0
Czechia
State/province [65] 0 0
Pardubice
Country [66] 0 0
Czechia
State/province [66] 0 0
Plzen
Country [67] 0 0
Czechia
State/province [67] 0 0
Trinec
Country [68] 0 0
Czechia
State/province [68] 0 0
Zlin
Country [69] 0 0
Denmark
State/province [69] 0 0
Danmark
Country [70] 0 0
Denmark
State/province [70] 0 0
Odense
Country [71] 0 0
France
State/province [71] 0 0
Angers
Country [72] 0 0
France
State/province [72] 0 0
Colmar Cedex
Country [73] 0 0
France
State/province [73] 0 0
Eaubonne-Montmorency
Country [74] 0 0
France
State/province [74] 0 0
Haguenau
Country [75] 0 0
France
State/province [75] 0 0
Nantes
Country [76] 0 0
France
State/province [76] 0 0
Paris Cedex 13
Country [77] 0 0
France
State/province [77] 0 0
Paris
Country [78] 0 0
France
State/province [78] 0 0
Pessac
Country [79] 0 0
France
State/province [79] 0 0
Rennes
Country [80] 0 0
France
State/province [80] 0 0
Rouen
Country [81] 0 0
France
State/province [81] 0 0
Saint Denis
Country [82] 0 0
France
State/province [82] 0 0
Strasbourg
Country [83] 0 0
France
State/province [83] 0 0
Toulouse Cedex 9
Country [84] 0 0
France
State/province [84] 0 0
Vandoeuvre les Nancy
Country [85] 0 0
Germany
State/province [85] 0 0
Baden-Wurttemberg
Country [86] 0 0
Germany
State/province [86] 0 0
Bavaria
Country [87] 0 0
Germany
State/province [87] 0 0
Hessen
Country [88] 0 0
Germany
State/province [88] 0 0
Lower Saxony
Country [89] 0 0
Germany
State/province [89] 0 0
Nordhein Westfalen
Country [90] 0 0
Germany
State/province [90] 0 0
Nordrhein Westfalen
Country [91] 0 0
Germany
State/province [91] 0 0
North Rhine-Westphalia
Country [92] 0 0
Germany
State/province [92] 0 0
Rhineland-Palatinate
Country [93] 0 0
Germany
State/province [93] 0 0
Schleswig Holstein
Country [94] 0 0
Germany
State/province [94] 0 0
Schleswig-Holstein
Country [95] 0 0
Germany
State/province [95] 0 0
Thuringia
Country [96] 0 0
Germany
State/province [96] 0 0
Wurrtemberg
Country [97] 0 0
Germany
State/province [97] 0 0
Bad Oeynhausen
Country [98] 0 0
Germany
State/province [98] 0 0
Berlin
Country [99] 0 0
Germany
State/province [99] 0 0
Hamburg
Country [100] 0 0
Italy
State/province [100] 0 0
Milano
Country [101] 0 0
Italy
State/province [101] 0 0
Padova
Country [102] 0 0
Italy
State/province [102] 0 0
Reggio Emilla
Country [103] 0 0
Italy
State/province [103] 0 0
Alessandria
Country [104] 0 0
Italy
State/province [104] 0 0
Bologna
Country [105] 0 0
Italy
State/province [105] 0 0
Bolzano
Country [106] 0 0
Italy
State/province [106] 0 0
Brescia
Country [107] 0 0
Italy
State/province [107] 0 0
Como
Country [108] 0 0
Italy
State/province [108] 0 0
Lecco
Country [109] 0 0
Italy
State/province [109] 0 0
Mantova
Country [110] 0 0
Italy
State/province [110] 0 0
Parma
Country [111] 0 0
Italy
State/province [111] 0 0
Pavia
Country [112] 0 0
Italy
State/province [112] 0 0
Pesaro
Country [113] 0 0
Italy
State/province [113] 0 0
Rimni
Country [114] 0 0
Italy
State/province [114] 0 0
Roma
Country [115] 0 0
Italy
State/province [115] 0 0
Torino
Country [116] 0 0
Italy
State/province [116] 0 0
Treviso
Country [117] 0 0
Netherlands
State/province [117] 0 0
BR
Country [118] 0 0
Netherlands
State/province [118] 0 0
LI
Country [119] 0 0
Netherlands
State/province [119] 0 0
NH
Country [120] 0 0
Netherlands
State/province [120] 0 0
OV
Country [121] 0 0
Netherlands
State/province [121] 0 0
UT
Country [122] 0 0
Netherlands
State/province [122] 0 0
ZH
Country [123] 0 0
New Zealand
State/province [123] 0 0
Canterbury
Country [124] 0 0
New Zealand
State/province [124] 0 0
Otago
Country [125] 0 0
New Zealand
State/province [125] 0 0
Waikoto
Country [126] 0 0
New Zealand
State/province [126] 0 0
Auckland
Country [127] 0 0
New Zealand
State/province [127] 0 0
Wellington
Country [128] 0 0
Poland
State/province [128] 0 0
Katowice - Ochojec
Country [129] 0 0
Poland
State/province [129] 0 0
Krakow
Country [130] 0 0
Poland
State/province [130] 0 0
Lodz
Country [131] 0 0
Poland
State/province [131] 0 0
Warszawa
Country [132] 0 0
Poland
State/province [132] 0 0
Wroclaw
Country [133] 0 0
Portugal
State/province [133] 0 0
Lisboa
Country [134] 0 0
Portugal
State/province [134] 0 0
Amadora
Country [135] 0 0
Portugal
State/province [135] 0 0
Coimbra
Country [136] 0 0
Portugal
State/province [136] 0 0
Porto
Country [137] 0 0
Portugal
State/province [137] 0 0
Vila Nova De Gala
Country [138] 0 0
Spain
State/province [138] 0 0
Barcelona
Country [139] 0 0
Spain
State/province [139] 0 0
Murcia
Country [140] 0 0
Spain
State/province [140] 0 0
Navarra
Country [141] 0 0
Spain
State/province [141] 0 0
Alicante
Country [142] 0 0
Spain
State/province [142] 0 0
Leon
Country [143] 0 0
Spain
State/province [143] 0 0
Madrid
Country [144] 0 0
Spain
State/province [144] 0 0
Malaga
Country [145] 0 0
Spain
State/province [145] 0 0
Sevilla
Country [146] 0 0
Sweden
State/province [146] 0 0
Umea
Country [147] 0 0
Sweden
State/province [147] 0 0
Uppsala
Country [148] 0 0
Switzerland
State/province [148] 0 0
Geneva
Country [149] 0 0
Switzerland
State/province [149] 0 0
Saint Gallen
Country [150] 0 0
Switzerland
State/province [150] 0 0
Thurgau
Country [151] 0 0
Switzerland
State/province [151] 0 0
Ticino
Country [152] 0 0
Switzerland
State/province [152] 0 0
Bassel

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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00091637