Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
PROTECTION AMI
Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction
2 other identifiers
interventional
1,180
18 countries
126
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2008
126 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedSeptember 2, 2011
August 1, 2011
1.7 years
November 3, 2008
August 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
During the index hospitalization
Secondary Outcomes (3)
The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
Within the first 3 months after Myocardial Infarction
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Within the first 3 months after Myocardial Infarction
Assess left ventricular function by imaging
Within the first 3 months after Myocardial Infarction
Study Arms (4)
A1: KAI-9803
EXPERIMENTALA2: KAI-9803
EXPERIMENTALA3: KAI-9803
EXPERIMENTALA4: Placebo
PLACEBO COMPARATORInterventions
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Persistent systolic blood pressure \< 90 mm Hg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KAI Pharmaceuticalslead
- Bristol-Myers Squibbcollaborator
- The Cleveland Cliniccollaborator
- Duke Universitycollaborator
Study Sites (126)
Unknown Facility
Huntsville, Alabama, 35801, United States
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Escondido, California, 92025, United States
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Torrance, California, 90509, United States
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Tampa, Florida, 33613, United States
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Atlanta, Georgia, 30309, United States
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Downers Grove, Illinois, 60515, United States
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Lombard, Illinois, 60148, United States
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Peoria, Illinois, 61602, United States
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Valparaiso, Indiana, 46383, United States
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Omaha, Nebraska, 68131, United States
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Williamsville, New York, 14221, United States
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Greensboro, North Carolina, 27410, United States
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High Point, North Carolina, 27262, United States
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Zanesville, Ohio, 43701, United States
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Oklahoma City, Oklahoma, 77030, United States
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Beaver, Pennsylvania, 15009, United States
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Danville, Pennsylvania, 17822, United States
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Bedford Park, Australia
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Boxhill, Australia
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Epping, Australia
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Fremantle, Australia
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Hobart, Australia
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Kogarah, Australia
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Liverpool, Australia
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Parkville, Australia
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Perth, Australia
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St Leonards, Australia
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Victoria, Australia
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Antwerp, Belgium
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Bonheiden, Belgium
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Brussels, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Kitchner, Ontario, Canada
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Newmarket, Ontario, Canada
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Toronta, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Sainte-Foy, Quebec, Canada
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New Brunswick, Canada
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Brno, Czechia
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Hradec Králové, Czechia
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Karlovy Vary, Czechia
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Labem, Czechia
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Liberec, Czechia
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Olomouc, Czechia
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Ostrava, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Zlín, Czechia
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Aalborg, Denmark
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Copenhagen, Denmark
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Hellerup, Denmark
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Odense, Denmark
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Helsinki, Finland
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Turku, Finland
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Berlin, Germany
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Halle, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Lübeck, Germany
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Magdeburg, Germany
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Mannheim, Germany
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München, Germany
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Rostock, Germany
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Budapest, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Székesfehérvár, Hungary
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Zalaegerszeg, Hungary
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Afula, Israel
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Ashkelon, Israel
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BeerSheva, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Safed, Israel
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Ẕerifin, Israel
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Pesaro, Italy
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Rome, Italy
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Rozzano, Italy
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Amsterdam, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Zwolle, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Dunedin, New Zealand
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Hamilton, New Zealand
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Nelson, New Zealand
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Arendal, Norway
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Bergen, Norway
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Bialystok, Poland
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Bielsko-Biala, Poland
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Dąbrowa Górnicza, Poland
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Gdansk, Poland
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Gdynia, Poland
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Krakow, Poland
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Lubin, Poland
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Poznan, Poland
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Szczecin, Poland
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Torun, Poland
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Warsaw, Poland
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Almada, Portugal
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Amadora, Portugal
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Carnaxide, Portugal
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Alicante, Spain
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Barcelona, Spain
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El Palmar Murcia, Spain
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León, Spain
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Madrid, Spain
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Santa Cruz de Tenerife, Spain
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Seville, Spain
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Vigo Pontevedra, Spain
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Gothenburg, Sweden
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Helsingborg, Sweden
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Linköping, Sweden
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Lund, Sweden
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Malmo, Sweden
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Örebro, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
Related Publications (1)
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.
PMID: 24796339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gregory Bell, MD
KAI Pharmaceuticals, Inc
- PRINCIPAL INVESTIGATOR
A.Michael Lincoff, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 5, 2008
Study Start
November 1, 2008
Primary Completion
July 1, 2010
Study Completion
May 1, 2011
Last Updated
September 2, 2011
Record last verified: 2011-08