Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
NCT ID: NCT00785954
Last Updated: 2011-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1180 participants
INTERVENTIONAL
2008-11-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A1: KAI-9803
KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
A2: KAI-9803
KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
A3: KAI-9803
KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
A4: Placebo
KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Interventions
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KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Eligibility Criteria
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Inclusion Criteria
* Continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
The Cleveland Clinic
OTHER
Duke University
OTHER
KAI Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Bell, MD
Role: STUDY_DIRECTOR
KAI Pharmaceuticals, Inc
A.Michael Lincoff, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Huntsville, Alabama, United States
Escondido, California, United States
Torrance, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Downers Grove, Illinois, United States
Lombard, Illinois, United States
Peoria, Illinois, United States
Valparaiso, Indiana, United States
Omaha, Nebraska, United States
Williamsville, New York, United States
Greensboro, North Carolina, United States
High Point, North Carolina, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Beaver, Pennsylvania, United States
Danville, Pennsylvania, United States
Bedford Park, , Australia
Boxhill, , Australia
Epping, , Australia
Fremantle, , Australia
Hobart, , Australia
Kogarah, , Australia
Liverpool, , Australia
Parkville, , Australia
Perth, , Australia
St Leonards, , Australia
Victoria, , Australia
Antwerp, , Belgium
Bonheiden, , Belgium
Brussels, , Belgium
Liège, , Belgium
Roeselare, , Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Kitchner, Ontario, Canada
Newmarket, Ontario, Canada
Toronta, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
New Brunswick, , Canada
Brno, , Czechia
Hradec Králové, , Czechia
Karlovy Vary, , Czechia
Labem, , Czechia
Liberec, , Czechia
Olomouc, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Zlín, , Czechia
Aalborg, , Denmark
Copenhagen, , Denmark
Hellerup, , Denmark
Odense, , Denmark
Helsinki, , Finland
Turku, , Finland
Berlin, , Germany
Halle, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Lübeck, , Germany
Magdeburg, , Germany
Mannheim, , Germany
München, , Germany
Rostock, , Germany
Budapest, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Zalaegerszeg, , Hungary
Afula, , Israel
Ashkelon, , Israel
BeerSheva, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Safed, , Israel
Ẕerifin, , Israel
Pesaro, , Italy
Rome, , Italy
Rozzano, , Italy
Amsterdam, , Netherlands
Nieuwegein, , Netherlands
Rotterdam, , Netherlands
Zwolle, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Dunedin, , New Zealand
Hamilton, , New Zealand
Nelson, , New Zealand
Arendal, , Norway
Bergen, , Norway
Bialystok, , Poland
Bielsko-Biala, , Poland
Dąbrowa Górnicza, , Poland
Gdansk, , Poland
Gdynia, , Poland
Krakow, , Poland
Lubin, , Poland
Poznan, , Poland
Szczecin, , Poland
Torun, , Poland
Warsaw, , Poland
Almada, , Portugal
Amadora, , Portugal
Carnaxide, , Portugal
Alicante, , Spain
Barcelona, , Spain
El Palmar Murcia, , Spain
León, , Spain
Madrid, , Spain
Santa Cruz de Tenerife, , Spain
Seville, , Spain
Vigo Pontevedra, , Spain
Gothenburg, , Sweden
Helsingborg, , Sweden
Linköping, , Sweden
Lund, , Sweden
Malmo, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Countries
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References
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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.
Other Identifiers
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EudraCT: 2008-005140-16
Identifier Type: -
Identifier Source: secondary_id
KAI-9803-004
Identifier Type: -
Identifier Source: org_study_id
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