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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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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United States of America
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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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New Brunswick
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Czech Republic
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Brno
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Hradec Kralove
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Karlovy vary
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Labem
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Liberec
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Aalborg
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Hellerup
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Odense
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Helsinki
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Lubeck
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Gdynia
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Krakow
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Lubin
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Poznan
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Torun
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Portugal
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Almada
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Portugal
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Amadora
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Carnaxide
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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El Palmar Murcia
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Spain
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Leon
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Tenerife
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Vigo Pontevedra
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Sweden
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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
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Sweden
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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/study/NCT00785954
Trial related presentations / publications
Lincoff AM, Roe M, Aylward P, Galla J, Rynkiewicz A, Guetta V, Zelizko M, Kleiman N, White H, McErlean E, Erlinge D, Laine M, Dos Santos Ferreira JM, Goodman S, Mehta S, Atar D, Suryapranata H, Jensen SE, Forster T, Fernandez-Ortiz A, Schoors D, Radke P, Belli G, Brennan D, Bell G, Krucoff M; PROTECTION AMI Investigators. Inhibition of delta-protein kinase C by delcasertib as an adjunct to primary percutaneous coronary intervention for acute anterior ST-segment elevation myocardial infarction: results of the PROTECTION AMI Randomized Controlled Trial. Eur Heart J. 2014 Oct 1;35(37):2516-23. doi: 10.1093/eurheartj/ehu177. Epub 2014 May 5.
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/study/NCT00785954