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

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
The Cleveland Clinic
Duke University
Information provided by (Responsible Party):
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00785954
First received: November 3, 2008
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  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). A select number of sites will also participate in a substudy where eligible patients will undergo an additional procedure;cardiac magnetic resonance imaging.


Condition Intervention Phase
Myocardial Infarction
Cardiovascular Diseases
Pathologic Processes
 Drug: KAI-9803
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 1180
Study Start Date: November 2008
Study Completion Date: May 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

  Show 127 Study Locations
Sponsors and Collaborators
KAI Pharmaceuticals
Bristol-Myers Squibb
The Cleveland Clinic
Duke University
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
ClinicalTrials.gov Identifier: NCT00785954     History of Changes
Other Study ID Numbers: KAI-9803-004, EudraCT: 2008-005140-16
Study First Received: November 3, 2008
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
European Union: European Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency

Keywords provided by KAI Pharmaceuticals:
Heart Diseases
Myocardial Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Cardiovascular Diseases
Infarction
Myocardial Infarction
Pathologic Processes
Ischemia
 Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013