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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/11/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2011
Sample size
Target
Accrual to date
Final
1180
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
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United States of America
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California
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Florida
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Georgia
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Illinois
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Indiana
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Nebraska
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Belgium
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Antwerp
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Belgium
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Bonheiden
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Belgium
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Brussels
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Belgium
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Liege
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Belgium
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Roeselare
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Canada
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Alberta
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British Columbia
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Ontario
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Quebec
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Canada
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New Brunswick
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Czech Republic
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Brno
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Hradec Kralove
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Czech Republic
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Karlovy vary
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Labem
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Liberec
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Olomouc
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Ostrava
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Plzen
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Prague
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Praha
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Czech Republic
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Zlin
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Aalborg
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Hellerup
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København
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Odense
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Finland
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Helsinki
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Finland
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Turku
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Germany
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Halle
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Heidelberg
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Lubeck
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Magdeburg
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Mannheim
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Munchen
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Germany
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Rostock
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Hungary
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Budapest
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Hungary
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Pecs
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Szeged
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Szekesfehervar
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Zalaegerszeg
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Afula
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Ashkelon
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Haifa
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Holon
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Safed
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Israel
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Zerifin
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Italy
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Pesaro
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Rome
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Rozzano
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Amsterdam
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Rotterdam
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Zwolle
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Auckland
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Christchurch
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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Nelson
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Norway
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Arendal
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Bergen
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Bielsko-Biala
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Dabrowa Górnicza
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Gdansk
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Gdynia
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Krakow
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Lubin
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Poznan
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Szczecin
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Torun
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Warsawa
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Portugal
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Almada
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Portugal
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Amadora
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Portugal
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Carnaxide
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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
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Sweden
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Helsingborg
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Sweden
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Linköping
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Sweden
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Lund
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Sweden
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Malmö
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Sweden
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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00785954