Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack] (PROTECTION AMI)

August 30, 2011 updated by: KAI Pharmaceuticals

Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1180

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Bedford Park, Australia
      • Boxhill, Australia
      • Epping, Australia
      • Fremantle, Australia
      • Hobart, Australia
      • Kogarah, Australia
      • Liverpool, Australia
      • Parkville, Australia
      • Perth, Australia
      • St Leonards, Australia
      • Victoria, Australia
  • Belgium
      • Antwerp, Belgium
      • Bonheiden, Belgium
      • Brussels, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
  • Canada
      • New Brunswick, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Kitchner, Ontario, Canada
      • Newmarket, Ontario, Canada
      • Toronta, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
      • Sainte-Foy, Quebec, Canada
  • Czech Republic
      • Brno, Czech Republic
      • Hradec Kralove, Czech Republic
      • Karlovy vary, Czech Republic
      • Labem, Czech Republic
      • Liberec, Czech Republic
      • Olomouc, Czech Republic
      • Ostrava, Czech Republic
      • Plzen, Czech Republic
      • Prague, Czech Republic
      • Praha, Czech Republic
      • Zlin, Czech Republic
  • Denmark
      • Aalborg, Denmark
      • Hellerup, Denmark
      • København, Denmark
      • Odense, Denmark
  • Finland
      • Helsinki, Finland
      • Turku, Finland
  • Germany
      • Berlin, Germany
      • Halle, Germany
      • Hamburg, Germany
      • Heidelberg, Germany
      • Lubeck, Germany
      • Magdeburg, Germany
      • Mannheim, Germany
      • Munchen, Germany
      • Rostock, Germany
  • Hungary
      • Budapest, Hungary
      • Pecs, Hungary
      • Szeged, Hungary
      • Szekesfehervar, Hungary
      • Zalaegerszeg, Hungary
  • Israel
      • Afula, Israel
      • Ashkelon, Israel
      • BeerSheva, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Safed, Israel
      • Zerifin, Israel
  • Italy
      • Pesaro, Italy
      • Rome, Italy
      • Rozzano, Italy
  • Netherlands
      • Amsterdam, Netherlands
      • Nieuwegein, Netherlands
      • Rotterdam, Netherlands
      • Zwolle, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Hamilton, New Zealand
      • Nelson, New Zealand
  • Norway
      • Arendal, Norway
      • Bergen, Norway
  • Poland
      • Bialystok, Poland
      • Bielsko-Biala, Poland
      • Dąbrowa Górnicza, Poland
      • Gdansk, Poland
      • Gdynia, Poland
      • Krakow, Poland
      • Lubin, Poland
      • Poznan, Poland
      • Szczecin, Poland
      • Toruń, Poland
      • Warsawa, Poland
  • Portugal
      • Almada, Portugal
      • Amadora, Portugal
      • Carnaxide, Portugal
  • Spain
      • Alicante, Spain
      • Barcelona, Spain
      • El Palmar Murcia, Spain
      • Leon, Spain
      • Madrid, Spain
      • Sevilla, Spain
      • Tenerife, Spain
      • Vigo Pontevedra, Spain
  • Sweden
      • Göteborg, Sweden
      • Helsingborg, Sweden
      • Linköping, Sweden
      • Lund, Sweden
      • Malmö, Sweden
      • Stockholm, Sweden
      • Sundsvall, Sweden
      • Örebro, Sweden
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
    • California
      • Escondido, California, United States, 92025
      • Torrance, California, United States, 90509
    • Florida
      • Tampa, Florida, United States, 33613
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Illinois
      • Downers Grove, Illinois, United States, 60515
      • Lombard, Illinois, United States, 60148
      • Peoria, Illinois, United States, 61602
    • Indiana
      • Valparaiso, Indiana, United States, 46383
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New York
      • Williamsville, New York, United States, 14221
    • North Carolina
      • Greensboro, North Carolina, United States, 27410
      • High Point, North Carolina, United States, 27262
    • Ohio
      • Zanesville, Ohio, United States, 43701
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 77030
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
      • Danville, Pennsylvania, United States, 17822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1: KAI-9803
Drug: KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Experimental: A2: KAI-9803
Drug: KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Experimental: A3: KAI-9803
Drug: KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Placebo Comparator: A4: Placebo
Drug: KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
Time Frame: During the index hospitalization
During the index hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
Time Frame: Within the first 3 months after Myocardial Infarction
Within the first 3 months after Myocardial Infarction
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Time Frame: Within the first 3 months after Myocardial Infarction
Within the first 3 months after Myocardial Infarction
Assess left ventricular function by imaging
Time Frame: Within the first 3 months after Myocardial Infarction
Within the first 3 months after Myocardial Infarction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KAI Pharmaceuticals

Collaborators

Bristol-Myers Squibb
The Cleveland Clinic
Duke University

Investigators

  • Principal Investigator: A.Michael Lincoff, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 3, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

August 30, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAI-9803-004
  • EudraCT: 2008-005140-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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