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

Inhibition of Delta-protein Kinase C for the Reduction of Infarct Size in Acute Myocardial Infarction

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00785954

Acronym

PROTECTION AMI

Enrollment

1180

Registered

2008-11-05

Start date

2008-11-30

Completion date

2011-05-31

Last updated

2011-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Myocardial Infarction, Pathologic Processes

Keywords

Heart Diseases, Myocardial Ischemia, Infarction, Myocardial Infarction

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.

Interventions

DRUGKAI-9803

STEMI Subjects will be randomly assigned to receive either KAI-9803 or Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The effect of KAI-9803 on infarct size as assessed by CK-MB AUC	During the index hospitalization

Secondary

Measure	Time frame
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

Countries

Australia, Belgium, Canada, Czechia, Denmark, Finland, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026