Status:
COMPLETED
Safety of KAI-9803 for Injection With Angioplasty Following Heart Attack
Lead Sponsor:
KAI Pharmaceuticals
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Restoring blood flow to coronary arteries as quickly as possible is the best way to reduce the damage to the muscle that occurs with a heart attack. However, up to 25-50% of patients who have angiopla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00093197
Start Date
September 1 2004
End Date
October 1 2006
Last Update
September 2 2011
Active Locations (1)
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1
Duke Clinical Research Institute
Durham, North Carolina, United States, 27715