COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

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/show/NCT00785954




Registration number
NCT00785954
Ethics application status
Date submitted
3/11/2008
Date registered
5/11/2008
Date last updated
2/09/2011

Titles & IDs
Public title
Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
Scientific title
Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction
Secondary ID [1] 0 0
EudraCT: 2008-005140-16
Secondary ID [2] 0 0
KAI-9803-004
Universal Trial Number (UTN)
Trial acronym
PROTECTION AMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Cardiovascular Diseases 0 0
Pathologic Processes 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 - KAI-9803

Experimental: A1: KAI-9803 -

Experimental: A2: KAI-9803 -

Experimental: A3: KAI-9803 -

Placebo Comparator: A4: Placebo -


Treatment: Drugs: KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
Timepoint [1] 0 0
During the index hospitalization
Secondary outcome [1] 0 0
The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
Timepoint [1] 0 0
Within the first 3 months after Myocardial Infarction
Secondary outcome [2] 0 0
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Timepoint [2] 0 0
Within the first 3 months after Myocardial Infarction
Secondary outcome [3] 0 0
Assess left ventricular function by imaging
Timepoint [3] 0 0
Within the first 3 months after Myocardial Infarction

Eligibility
Key inclusion criteria
- Acute STEMI and has a planned emergent primary PCI procedure

- Continuous symptoms of cardiac ischemia and present to the primary PCI facility within
6 hours of symptom onset
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Persistent systolic blood pressure < 90 mm Hg

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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)
Recruitment hospital [1] 0 0
- Bedford Park
Recruitment hospital [2] 0 0
- Boxhill
Recruitment hospital [3] 0 0
- Epping
Recruitment hospital [4] 0 0
- Fremantle
Recruitment hospital [5] 0 0
- Hobart
Recruitment hospital [6] 0 0
- Kogarah
Recruitment hospital [7] 0 0
- Liverpool
Recruitment hospital [8] 0 0
- Parkville
Recruitment hospital [9] 0 0
- Perth
Recruitment hospital [10] 0 0
- St Leonards
Recruitment hospital [11] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Boxhill
Recruitment postcode(s) [3] 0 0
- Epping
Recruitment postcode(s) [4] 0 0
- Fremantle
Recruitment postcode(s) [5] 0 0
- Hobart
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Liverpool
Recruitment postcode(s) [8] 0 0
- Parkville
Recruitment postcode(s) [9] 0 0
- Perth
Recruitment postcode(s) [10] 0 0
- St Leonards
Recruitment postcode(s) [11] 0 0
- Victoria
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
Belgium
State/province [13] 0 0
Antwerp
Country [14] 0 0
Belgium
State/province [14] 0 0
Bonheiden
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Liege
Country [17] 0 0
Belgium
State/province [17] 0 0
Roeselare
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Canada
State/province [22] 0 0
New Brunswick
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Brno
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Karlovy vary
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Labem
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Liberec
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Olomouc
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Ostrava
Country [30] 0 0
Czech Republic
State/province [30] 0 0
Plzen
Country [31] 0 0
Czech Republic
State/province [31] 0 0
Prague
Country [32] 0 0
Czech Republic
State/province [32] 0 0
Praha
Country [33] 0 0
Czech Republic
State/province [33] 0 0
Zlin
Country [34] 0 0
Denmark
State/province [34] 0 0
Aalborg
Country [35] 0 0
Denmark
State/province [35] 0 0
Hellerup
Country [36] 0 0
Denmark
State/province [36] 0 0
København
Country [37] 0 0
Denmark
State/province [37] 0 0
Odense
Country [38] 0 0
Finland
State/province [38] 0 0
Helsinki
Country [39] 0 0
Finland
State/province [39] 0 0
Turku
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Halle
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Heidelberg
Country [44] 0 0
Germany
State/province [44] 0 0
Lubeck
Country [45] 0 0
Germany
State/province [45] 0 0
Magdeburg
Country [46] 0 0
Germany
State/province [46] 0 0
Mannheim
Country [47] 0 0
Germany
State/province [47] 0 0
Munchen
Country [48] 0 0
Germany
State/province [48] 0 0
Rostock
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Pecs
Country [51] 0 0
Hungary
State/province [51] 0 0
Szeged
Country [52] 0 0
Hungary
State/province [52] 0 0
Szekesfehervar
Country [53] 0 0
Hungary
State/province [53] 0 0
Zalaegerszeg
Country [54] 0 0
Israel
State/province [54] 0 0
Afula
Country [55] 0 0
Israel
State/province [55] 0 0
Ashkelon
Country [56] 0 0
Israel
State/province [56] 0 0
BeerSheva
Country [57] 0 0
Israel
State/province [57] 0 0
Haifa
Country [58] 0 0
Israel
State/province [58] 0 0
Holon
Country [59] 0 0
Israel
State/province [59] 0 0
Jerusalem
Country [60] 0 0
Israel
State/province [60] 0 0
Kfar Saba
Country [61] 0 0
Israel
State/province [61] 0 0
Safed
Country [62] 0 0
Israel
State/province [62] 0 0
Zerifin
Country [63] 0 0
Italy
State/province [63] 0 0
Pesaro
Country [64] 0 0
Italy
State/province [64] 0 0
Rome
Country [65] 0 0
Italy
State/province [65] 0 0
Rozzano
Country [66] 0 0
Netherlands
State/province [66] 0 0
Amsterdam
Country [67] 0 0
Netherlands
State/province [67] 0 0
Nieuwegein
Country [68] 0 0
Netherlands
State/province [68] 0 0
Rotterdam
Country [69] 0 0
Netherlands
State/province [69] 0 0
Zwolle
Country [70] 0 0
New Zealand
State/province [70] 0 0
Auckland
Country [71] 0 0
New Zealand
State/province [71] 0 0
Christchurch
Country [72] 0 0
New Zealand
State/province [72] 0 0
Dunedin
Country [73] 0 0
New Zealand
State/province [73] 0 0
Hamilton
Country [74] 0 0
New Zealand
State/province [74] 0 0
Nelson
Country [75] 0 0
Norway
State/province [75] 0 0
Arendal
Country [76] 0 0
Norway
State/province [76] 0 0
Bergen
Country [77] 0 0
Poland
State/province [77] 0 0
Bialystok
Country [78] 0 0
Poland
State/province [78] 0 0
Bielsko-Biala
Country [79] 0 0
Poland
State/province [79] 0 0
Dabrowa Górnicza
Country [80] 0 0
Poland
State/province [80] 0 0
Gdansk
Country [81] 0 0
Poland
State/province [81] 0 0
Gdynia
Country [82] 0 0
Poland
State/province [82] 0 0
Krakow
Country [83] 0 0
Poland
State/province [83] 0 0
Lubin
Country [84] 0 0
Poland
State/province [84] 0 0
Poznan
Country [85] 0 0
Poland
State/province [85] 0 0
Szczecin
Country [86] 0 0
Poland
State/province [86] 0 0
Torun
Country [87] 0 0
Poland
State/province [87] 0 0
Warsawa
Country [88] 0 0
Portugal
State/province [88] 0 0
Almada
Country [89] 0 0
Portugal
State/province [89] 0 0
Amadora
Country [90] 0 0
Portugal
State/province [90] 0 0
Carnaxide
Country [91] 0 0
Spain
State/province [91] 0 0
Alicante
Country [92] 0 0
Spain
State/province [92] 0 0
Barcelona
Country [93] 0 0
Spain
State/province [93] 0 0
El Palmar Murcia
Country [94] 0 0
Spain
State/province [94] 0 0
Leon
Country [95] 0 0
Spain
State/province [95] 0 0
Madrid
Country [96] 0 0
Spain
State/province [96] 0 0
Sevilla
Country [97] 0 0
Spain
State/province [97] 0 0
Tenerife
Country [98] 0 0
Spain
State/province [98] 0 0
Vigo Pontevedra
Country [99] 0 0
Sweden
State/province [99] 0 0
Göteborg
Country [100] 0 0
Sweden
State/province [100] 0 0
Helsingborg
Country [101] 0 0
Sweden
State/province [101] 0 0
Linköping
Country [102] 0 0
Sweden
State/province [102] 0 0
Lund
Country [103] 0 0
Sweden
State/province [103] 0 0
Malmö
Country [104] 0 0
Sweden
State/province [104] 0 0
Stockholm
Country [105] 0 0
Sweden
State/province [105] 0 0
Sundsvall
Country [106] 0 0
Sweden
State/province [106] 0 0
Örebro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
KAI Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Cleveland Clinic
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Duke University
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether KAI-9803 is safe and effective in reducing
infarct size in subjects with ST elevation myocardial infarction (heart attack) undergoing a
percutaneous coronary intervention (PCI). A select number of sites will also participate in a
substudy where eligible patients will undergo an additional procedure;cardiac magnetic
resonance imaging.
Trial website
https://clinicaltrials.gov/show/NCT00785954
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gregory Bell, MD
Address 0 0
KAI Pharmaceuticals, Inc
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