Clinical trial NCT00785954: Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
Official title: Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myocardial Infarction
Cardiovascular Diseases
Pathologic Processes
Keywords: Heart Diseases
Myocardial Ischemia
Infarction
Myocardial Infarction
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: The Cleveland Clinic
name: Duke University
First posted: 2008-11-05
Enrollment: 1180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Exclusion Criteria:

* Persistent systolic blood pressure \< 90 mm Hg

Primary outcomes:
measure: The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
timeFrame: During the index hospitalization
Secondary outcomes:
measure: The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
timeFrame: Within the first 3 months after Myocardial Infarction
measure: The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
timeFrame: Within the first 3 months after Myocardial Infarction
measure: Assess left ventricular function by imaging
timeFrame: Within the first 3 months after Myocardial Infarction
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Escondido
country: United States
state: California
city: Torrance
country: United States
state: California
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Downers Grove
country: United States
state: Illinois
city: Lombard
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Valparaiso
country: United States
state: Indiana
city: Omaha
country: United States
state: Nebraska
city: Williamsville
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Zanesville
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Beaver
country: United States
state: Pennsylvania
city: Danville
country: United States
state: Pennsylvania
city: Bedford Park
country: Australia
city: Boxhill
country: Australia
city: Epping
country: Australia
city: Fremantle
country: Australia
city: Hobart
country: Australia
city: Kogarah
country: Australia
city: Liverpool
country: Australia
city: Parkville
country: Australia
city: Perth
country: Australia
city: St Leonards
country: Australia
city: Victoria
country: Australia
city: Antwerp
country: Belgium
city: Bonheiden
country: Belgium
city: Brussels
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Kitchner
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Toronta
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: New Brunswick
country: Canada
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Karlovy vary
country: Czech Republic
city: Labem
country: Czech Republic
city: Liberec
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Plzen
country: Czech Republic
city: Prague
country: Czech Republic
city: Praha
country: Czech Republic
city: Zlin
country: Czech Republic
city: Aalborg
country: Denmark
city: Hellerup
country: Denmark
city: København
country: Denmark
city: Odense
country: Denmark
city: Helsinki
country: Finland
city: Turku
country: Finland
city: Berlin
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Lubeck
country: Germany
city: Magdeburg
country: Germany
city: Mannheim
country: Germany
city: Munchen
country: Germany
city: Rostock
country: Germany
city: Budapest
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Afula
country: Israel
city: Ashkelon
country: Israel
city: BeerSheva
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Safed
country: Israel
city: Zerifin
country: Israel
city: Pesaro
country: Italy
city: Rome
country: Italy
city: Rozzano
country: Italy
city: Amsterdam
country: Netherlands
city: Nieuwegein
country: Netherlands
city: Rotterdam
country: Netherlands
city: Zwolle
country: Netherlands
city: Auckland
country: New Zealand
city: Christchurch
country: New Zealand
city: Dunedin
country: New Zealand
city: Hamilton
country: New Zealand
city: Nelson
country: New Zealand
city: Arendal
country: Norway
city: Bergen
country: Norway
city: Bialystok
country: Poland
city: Bielsko-Biala
country: Poland
city: Dąbrowa Górnicza
country: Poland
city: Gdansk
country: Poland
city: Gdynia
country: Poland
city: Krakow
country: Poland
city: Lubin
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Toruń
country: Poland
city: Warsawa
country: Poland
city: Almada
country: Portugal
city: Amadora
country: Portugal
city: Carnaxide
country: Portugal
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: El Palmar Murcia
country: Spain
city: Leon
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Tenerife
country: Spain
city: Vigo Pontevedra
country: Spain
city: Göteborg
country: Sweden
city: Helsingborg
country: Sweden
city: Linköping
country: Sweden
city: Lund
country: Sweden
city: Malmö
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Örebro
country: Sweden
Study officials:
affiliation: KAI Pharmaceuticals, Inc
name: Gregory Bell, MD
role: STUDY_DIRECTOR
affiliation: The Cleveland Clinic
name: A.Michael Lincoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.