Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
NCT00785954 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1180
Last updated 2011-09-02
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.
Conditions
- Myocardial Infarction
- Cardiovascular Diseases
- Pathologic Processes
Interventions
- DRUG
-
KAI-9803
STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo
Sponsors & Collaborators
- collaborator INDUSTRY
-
The Cleveland Clinic
collaborator OTHER - collaborator OTHER
-
KAI Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Gregory Bell, MD · KAI Pharmaceuticals, Inc
-
A.Michael Lincoff, MD · The Cleveland Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-11-30
- Primary Completion
- 2010-07-31
- Completion
- 2011-05-31
Countries
- United States
- Australia
- Belgium
- Canada
- Czechia
- Denmark
- Finland
- Germany
- Hungary
- Israel
- Italy
- Netherlands
- New Zealand
- Norway
- Poland
- Portugal
- Spain
- Sweden
Study Locations
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