Inhibition of d-PROTEin kinase C for the reducTION of infarct size in Acute Myocardial Infarction (PROTECTION AMI) - PROTECTION AMI

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1058

Inclusion Criteria

a. Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
b. Subject is at least 18 years old.
c. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test confirmed before randomization. WOCBP must be willing to use an acceptable method of contraception to avoid pregnancy for 10 days after randomization.
d. Subject presents with acute STEMI and has a planned emergent primary PCI procedure.
e. Subject must have a minimum of 30 minutes of continuous symptoms of cardiac ischemia and present to the primary PCI facility within 6 hours of symptom onset.
f. Subject must have persistent ST elevation of: = 2 mm in at least two contiguous precordial leads indicative of anterior MI location (leads V1-V4; anterior STEMI cohort) or persistent ST elevation of = 2 mm in two inferior leads (leads II, III or aVF) coupled with ST depression in two contiguous anterior leads for a total of at least 8 mm (inferior STEMI cohort).
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

a. Intraventricular conduction defect (including left bundle branch block), or paced rhythm that would obscure the diagnosis of acute STEMI.
b. Persistent systolic blood pressure <90 mm Hg (i.e., unresponsive to IV fluids).
c. Currently receiving vasopressors (e.g., norepinephrine) or inotropes (e.g., dobutamine).
d. History of end stage renal disease requiring hemodialysis or peritoneal dialysis.
e. Known history of severe hepatic dysfunction (e.g., cirrhosis, ascites) or clinically jaundiced at randomization.
f. Any prior coronary artery bypass grafting (CABG).
g. Treatment with intravenous fibrinolytic therapy (e.g., alteplase, reteplase, tenecteplase, and streptokinase) within the 72 hours prior to presentation.
h. Women who are pregnant or breast-feeding.
i. Inability to comply with study procedures, including inability to undergo cardiac catheterization or primary PCI.
j. Serious concurrent medical condition (e.g. malignancy) likely to result in death during next 12 months.
k. Participation in a study of experimental therapy (drug or device) within 30 days of presentation.
l. Clinical suspicion of non-thrombotic (e.g., pericarditis, vasospasm, illicit drug use) cause for ST-segment elevation as determined by the Investigator.
m. Prior participation in this study.
n. Prisoners or subjects who are involuntarily incarcerated.
o. Subjects who are compulsorily detained for the treatment of either psychiatric or physical (e.g., infectious disease) illness.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials