Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
Phase 2
Completed
- Conditions
- Myocardial InfarctionCardiovascular DiseasesPathologic Processes
- Interventions
- Registration Number
- NCT00785954
- Lead Sponsor
- KAI Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1180
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1: KAI-9803 KAI-9803 - A2: KAI-9803 KAI-9803 - A3: KAI-9803 KAI-9803 - A4: Placebo KAI-9803 -
- Primary Outcome Measures
Name Time Method The effect of KAI-9803 on infarct size as assessed by CK-MB AUC During the index hospitalization
- Secondary Outcome Measures
Name Time Method 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