Acute myocardial infarction with ST elevation MedDRA version: 7.1 Level: PT Classification code 10000891
Conditions
Interventions
Product Name: KAI-9803 For Injection
Product Code: KAI-9803
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: KAI-9803
CAS Number: none
Current Sponsor code: KAI-9803
Other
Sponsors
KAI Pharmaceuticals Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must:- - have experienced symptoms of cardiac ischemia at rest or with increasing frequency (angina or anginal equivalent) , with episodes lasting for at least 30 minutes within 6 hours of presentation - have persistent segment elevation of more than 0.2mV in at least 2 contiguous precordial leads indicative of anterior MI location (Leads V1-V4) - be not less than 18 years old - have complete occlusion of the left anterior descending artery (TIMI 0-1 flow) demonstrated on the initial angiogram - other criteria in the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must be excluded for:- - any left bundle branch block (new or old), intraventricular conduction defect, or paced rhythm that would obscure the diagnosis of acute anterior STEMI - any prior documented MI including old Q waves documented on prior ECGs or a clinical history of definite MI - any prior coronary artery bypass grafting - cardiogenic shock at initial presentation, consisting of persistent hypotension (systolic blood pressure 20 minutes) and signs of end-organ dysfunction (oliguria, alterred mental status, poor peripheral perfusion or lactic acidosis). - known baseline serum creatinine > 2.5 mg/dL without renal dialysis or renal replacement therapy within 30 days before presentation - other criteria in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and effect on myocardial function of various doses of KAI-9803 For Injection when administered by intra coronary injection during primary PCI (percutaneous intervention) for acute ST-elevation myocardial infarction (STEMI). ;Secondary Objective: The effect of KAI-9803 on multiple biomarkers that reflect myocardial viability and myocardial tissue perfusion will be assessed both as a measure of safety and to evaluate potential efficacy endpoints for a future approval-directed clinical trial. ;Primary end point(s): Safety endpoints, according to the procedures and timeframes in the protocol, include spcific metrics at each of the following:- - hospitalization - 30 day clinical follow up - 6 month clinical follow up This study is not powered to demonstrate efficacy by clinica or surrogate endpoints. A number of surrogate endpoints will be evaluated to determine the effect of KAI-9803 on myocardial tissue perfusion, infarct size and left ventricular function. These surrogate endpoints will be utilized both as a measure of safety and to evaluate potential efficacy endpoints for a future approval-directed clinical trial. - other endpoints in the protocol | — |
Countries
Austria, Czech Republic, Germany
Outcome results
None listed