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

KAI Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cardiovascular Diseases; Myocardial Infarction; Pathologic Processes

Treatments: Drug: KAI-9803

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00785954

EudraCT: 2008-005140-16

KAI-9803-004

Details and patient eligibility

About

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.

Enrollment: 1,180 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,180 participants in 4 patient groups, including a placebo group

A1: KAI-9803

Experimental group

Treatment:

Drug: KAI-9803

A2: KAI-9803

Experimental group

Treatment:

Drug: KAI-9803

A3: KAI-9803

Experimental group

Treatment:

Drug: KAI-9803

A4: Placebo

Placebo Comparator group

Treatment:

Drug: KAI-9803