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

Sponsor

KAI Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00785954

Collaborator

Bristol-Myers Squibb (Industry), The Cleveland Clinic (Other), Duke University (Other)

1,180

Enrollment

127

Locations

Arms

29.9

Duration (Months)

9.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Cardiovascular Diseases Pathologic Processes	Drug: KAI-9803	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

The effect of KAI-9803 on infarct size as assessed by CK-MB AUC [During the index hospitalization]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Huntsville	Alabama	United States	35801
2	Escondido	California	United States	92025
3	Torrance	California	United States	90509
4	Tampa	Florida	United States	33613
5	Atlanta	Georgia	United States	30309
6	Downers Grove	Illinois	United States	60515
7	Lombard	Illinois	United States	60148
8	Peoria	Illinois	United States	61602
9	Valparaiso	Indiana	United States	46383
10	Omaha	Nebraska	United States	68131
11	Williamsville	New York	United States	14221
12	Greensboro	North Carolina	United States	27410
13	High Point	North Carolina	United States	27262
14	Zanesville	Ohio	United States	43701
15	Oklahoma City	Oklahoma	United States	77030
16	Beaver	Pennsylvania	United States	15009
17	Danville	Pennsylvania	United States	17822
18	Bedford Park		Australia
19	Boxhill		Australia
20	Epping		Australia
21	Fremantle		Australia
22	Hobart		Australia
23	Kogarah		Australia
24	Liverpool		Australia
25	Parkville		Australia
26	Perth		Australia
27	St Leonards		Australia
28	Victoria		Australia
29	Antwerp		Belgium
30	Bonheiden		Belgium
31	Brussels		Belgium
32	Liege		Belgium
33	Roeselare		Belgium
34	Edmonton	Alberta	Canada
35	Vancouver	British Columbia	Canada
36	Hamilton	Ontario	Canada
37	Kitchner	Ontario	Canada
38	Newmarket	Ontario	Canada
39	Toronta	Ontario	Canada
40	Toronto	Ontario	Canada
41	Montreal	Quebec	Canada
42	Sainte-Foy	Quebec	Canada
43	New Brunswick		Canada
44	Brno		Czech Republic
45	Hradec Kralove		Czech Republic
46	Karlovy vary		Czech Republic
47	Labem		Czech Republic
48	Liberec		Czech Republic
49	Olomouc		Czech Republic
50	Ostrava		Czech Republic
51	Plzen		Czech Republic
52	Prague		Czech Republic
53	Praha		Czech Republic
54	Zlin		Czech Republic
55	Aalborg		Denmark
56	Hellerup		Denmark
57	København		Denmark
58	Odense		Denmark
59	Helsinki		Finland
60	Turku		Finland
61	Berlin		Germany
62	Halle		Germany
63	Hamburg		Germany
64	Heidelberg		Germany
65	Lubeck		Germany
66	Magdeburg		Germany
67	Mannheim		Germany
68	Munchen		Germany
69	Rostock		Germany
70	Budapest		Hungary
71	Pecs		Hungary
72	Szeged		Hungary
73	Szekesfehervar		Hungary
74	Zalaegerszeg		Hungary
75	Afula		Israel
76	Ashkelon		Israel
77	BeerSheva		Israel
78	Haifa		Israel
79	Holon		Israel
80	Jerusalem		Israel
81	Kfar Saba		Israel
82	Safed		Israel
83	Zerifin		Israel
84	Pesaro		Italy
85	Rome		Italy
86	Rozzano		Italy
87	Amsterdam		Netherlands
88	Nieuwegein		Netherlands
89	Rotterdam		Netherlands
90	Zwolle		Netherlands
91	Auckland		New Zealand
92	Christchurch		New Zealand
93	Dunedin		New Zealand
94	Hamilton		New Zealand
95	Nelson		New Zealand
96	Arendal		Norway
97	Bergen		Norway
98	Bialystok		Poland
99	Bielsko-Biala		Poland
100	Dąbrowa Górnicza		Poland
101	Gdansk		Poland
102	Gdynia		Poland
103	Krakow		Poland
104	Lubin		Poland
105	Poznan		Poland
106	Szczecin		Poland
107	Toruń		Poland
108	Warsawa		Poland
109	Almada		Portugal
110	Amadora		Portugal
111	Carnaxide		Portugal
112	Alicante		Spain
113	Barcelona		Spain
114	El Palmar Murcia		Spain
115	Leon		Spain
116	Madrid		Spain
117	Sevilla		Spain
118	Tenerife		Spain
119	Vigo Pontevedra		Spain
120	Göteborg		Sweden
121	Helsingborg		Sweden
122	Linköping		Sweden
123	Lund		Sweden
124	Malmö		Sweden
125	Stockholm		Sweden
126	Sundsvall		Sweden
127	Örebro		Sweden