This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026.
The study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).
Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures
Men between 18-85 years of age and post-menopausal women up to 85 years of age
Acute onset of chest pain of < 12 hours duration
STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI)
Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
Previous exposure to RTP-026
Time from symptoms onset to primary PCI > 12 hours
Previous CABG
Parallel
RTP-026
DrugIntervention is for each subject administered as three 30-minutes infusions of either A: 25μg/kg RTP-026; or B: ≥ 26μg/kg and ≤75μg/kg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B;
Placebo
DrugIntervention is for each subject administered as three 30-minutes infusions of placebo
Change in Cardiac Troponin T (cTNT)
Change in cTnT determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.
Change in Creatinine kinase-MB (CK-MB)
Change in CK-MB determined in blood samples taken at Baseline, 6 hours post-PCI, before the infusion 3 and 24 hours post-PCI.
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