Safety of KAI-9803 for Injection With Angioplasty Following Heart Attack
Myocardial Infarction
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
Inclusion Criteria: Symptoms of cardiac ischemia at rest or with increasing frequency (angina or angina equivalent), with episodes lasting for at least 30 minutes within 6 hours of presentation Persistent ST-segment elevation of ≥ 0.2 mV in at least 2 contiguous precordial leads indicative of anterior Myocardial Infarction (MI) location (leads V1-V4) At least 18 years old Complete occlusion of the left anterior descending artery (Thrombolysis in Myocardial Infarction (TIMI) 0-1 flow) demonstrated on the initial angiogram Culprit lesion suitable for primary percutaneous coronary intervention (PCI) Exclusion Criteria: Any left bundle branch block (new or old), intraventricular conduction defect, or paced rhythm that would obscure the diagnosis of acute anterior ST Elevation Myocardial Infarction (STEMI) Any prior documented myocardial infarction (MI), including old Q waves documented on prior ECGs or a clinical history of definite MI Any prior coronary artery bypass grafting (CABG) Cardiogenic shock at initial hospital presentation, consisting of persistent hypotension (systolic blood pressure < 90 mm Hg for > 20 minutes) and signs of end-organ dysfunction (oliguria, altered mental status, poor peripheral perfusion, and lactic acidosis) TIMI grade 2 or 3 flow in the left anterior descending artery documented on the initial diagnostic angiogram Culprit lesion in the left anterior descending artery that is not suitable for primary PCI Treatment with intravenous fibrinolytic therapy (i.e. alteplase, reteplase, tenecteplase, or streptokinase) within the 24 hours before presentation Pregnancy Know baseline creatinine > 2.5 mg/dL without renal dialysis/renal replacement therapy within the 30 days before presentation Inability to comply with study procedures, inability to undergo cardiac catheterization or primary percutaneous coronary intervention (PCI) Participation in a study of experimental therapy (drug or device) within 30 days of presentation, or prior participation in this study
Sites / Locations
- Duke Clinical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
A1: KAI-9803
A2: KAI-9803
A3: KAI-9803
A4: KAI-9803
A5: Placebo