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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014