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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction Cardiovascular Diseases Pathologic Processes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A1: KAI-9803

Group Type EXPERIMENTAL

KAI-9803

Intervention Type DRUG

STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

A2: KAI-9803

Group Type EXPERIMENTAL

KAI-9803

Intervention Type DRUG

STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

A3: KAI-9803

Group Type EXPERIMENTAL

KAI-9803

Intervention Type DRUG

STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

A4: Placebo

Group Type PLACEBO_COMPARATOR

KAI-9803

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

KAI Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Escondido, California, United States

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Torrance, California, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Downers Grove, Illinois, United States

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Lombard, Illinois, United States

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Peoria, Illinois, United States

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Valparaiso, Indiana, United States

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Omaha, Nebraska, United States

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Williamsville, New York, United States

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Greensboro, North Carolina, United States

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High Point, North Carolina, United States

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Zanesville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Beaver, Pennsylvania, United States

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Danville, Pennsylvania, 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

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Countries

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United States Australia Belgium Canada Czechia Denmark Finland Germany Hungary Israel Italy Netherlands New Zealand Norway Poland Portugal Spain Sweden

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.

Reference Type DERIVED
PMID: 24796339 (View on PubMed)

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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