drugset / Trial / NCT00785954
Safety and Efficacy Study of KAI-9803 to Treat Subjects With ST Elevation Myocardial Infarction [Heart Attack]
Phase 2
Completed
1180 enrolled
KAI Pharmaceuticals
Bristol-Myers Squibb · collabDuke University · collabThe Cleveland Clinic · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2008-11
- Primary completion
- 2010-07
- Completion
- 2011-05
Outcome
Missed primary endpoint
paper There were no differences between treatment groups in the primary efficacy endpoint of infarct size measured by creatine kinase MB fraction area under the curve PMID 24796339 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KAI-9803 | Unknown | 50 mg | Intravenous |
| Subject | KAI-9803 | Unknown | 150 mg | Intravenous |
| Subject | KAI-9803 | Unknown | 450 mg | Intravenous |