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

Primary Purpose

Myocardial Infarction, Cardiovascular Diseases, Pathologic Processes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KAI-9803
Sponsored by
KAI Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Heart Diseases, Myocardial Ischemia, Infarction, Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

A1: KAI-9803

A2: KAI-9803

A3: KAI-9803

A4: Placebo

Arm Description

Outcomes

Primary Outcome Measures

The effect of KAI-9803 on infarct size as assessed by CK-MB AUC

Secondary Outcome Measures

The effect of KAI-9803 on the incidence of the composite of cardiovascular death, heart failure, or serious ventricular arrhythmias
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Assess left ventricular function by imaging

Full Information

First Posted
November 3, 2008
Last Updated
August 30, 2011
Sponsor
KAI Pharmaceuticals
Collaborators
Bristol-Myers Squibb, The Cleveland Clinic, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT00785954
Brief Title
Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
Acronym
PROTECTION AMI
Official Title
Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KAI Pharmaceuticals
Collaborators
Bristol-Myers Squibb, The Cleveland Clinic, Duke University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Cardiovascular Diseases, Pathologic Processes
Keywords
Heart Diseases, Myocardial Ischemia, Infarction, Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1: KAI-9803
Arm Type
Experimental
Arm Title
A2: KAI-9803
Arm Type
Experimental
Arm Title
A3: KAI-9803
Arm Type
Experimental
Arm Title
A4: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KAI-9803
Intervention Description
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Primary Outcome Measure Information:
Title
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC
Time Frame
During the index hospitalization
Secondary Outcome Measure Information:
Title
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
Title
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI
Time Frame
Within the first 3 months after Myocardial Infarction
Title
Assess left ventricular function by imaging
Time Frame
Within the first 3 months after Myocardial Infarction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Bell, MD
Organizational Affiliation
KAI Pharmaceuticals, Inc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
A.Michael Lincoff, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
77030
Country
United States
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
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
State/Province
Alberta
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Hamilton
State/Province
Ontario
Country
Canada
City
Kitchner
State/Province
Ontario
Country
Canada
City
Newmarket
State/Province
Ontario
Country
Canada
City
Toronta
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Sainte-Foy
State/Province
Quebec
Country
Canada
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

12. IPD Sharing Statement

Citations:
PubMed Identifier
24796339
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.
Results Reference
derived

Learn more about this trial

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

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