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

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

This study is currently recruiting participants.

Verified by KAI Pharmaceuticals, April 2009

First Received: November 3, 2008 Last Updated: April 14, 2009 History of Changes

Sponsors and Collaborators:	KAI Pharmaceuticals Bristol-Myers Squibb The Cleveland Clinic Medpace, Inc. Flinders Medical Centre
Information provided by:	KAI Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00785954

Purpose

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)

Condition	Intervention	Phase
Myocardial Infarction Cardiovascular Diseases Pathologic Processes	Drug: KAI-9803	Phase II

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Inhibition of Delta-Protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction

Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:

The effect of KAI-9803 on infarct size as assessed by CK-MB AUC [ Time Frame: During the index hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The safety and tolerability of KAI-9803 by IV infusion to acute STEMI [ Time Frame: Within the first 3 months after Myocardial Infarction ] [ Designated as safety issue: No ]
Assess left ventricular function by imaging [ Time Frame: Within the first 3 months after Myocardial Infarction ] [ Designated as safety issue: No ]

Estimated Enrollment:	1058
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: KAI-9803: Experimental	Drug: KAI-9803 STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
A2: KAI-9803: Experimental	Drug: KAI-9803 STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
A3: KAI-9803: Experimental	Drug: KAI-9803 STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
A4: Placebo: Placebo Comparator	Drug: KAI-9803 STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785954

Contacts

Contact: Kathy Rathje (Medpace)

513-579-9911 ext 2264

Show 32 Study Locations

Sponsors and Collaborators

KAI Pharmaceuticals

Bristol-Myers Squibb

The Cleveland Clinic

Medpace, Inc.

Flinders Medical Centre

Investigators

Study Director:	Gregory Bell, MD	KAI Pharmaceuticals, Inc
Principal Investigator:	A.Michael Lincoff, MD	The Cleveland Clinic

More Information

No publications provided

Responsible Party:	KAI Pharmaceuticals, Inc. ( Gregory Bell, MD, Chief Medical Officer and Senior VP of Development )
Study ID Numbers:	KAI-9803-004, EudraCT: 2008-005140-16
Study First Received:	November 3, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00785954 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe

Keywords provided by KAI Pharmaceuticals:

Heart Diseases
Myocardial Ischemia
Infarction
Myocardial Infarction

Study placed in the following topic categories:

Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009