Trial Review

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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
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United States of America
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Alabama
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California
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Florida
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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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Bonheiden
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Brussels
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Liege
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Roeselare
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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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Brno
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Hradec Kralove
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Labem
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Zlin
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Aalborg
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Carnaxide
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Alicante
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Barcelona
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El Palmar Murcia
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Leon
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Madrid
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Sevilla
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Tenerife
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Vigo Pontevedra
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Helsingborg
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Lund
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Malmö
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Stockholm
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Sundsvall
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Sweden
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00785954