Acute Myocardial Infarction Clinical Trial
Official title:
Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab® (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double Blind, Placebo-controlled and Parallel Group Trial
Exploratory Phase II Clinical Trial to Evaluate the Efficacy and Safety of Clotinab® (Abciximab) in Acute Myocardial Infarction Patients: Multicenter, Randomized, Double-Blind, Placebo-controlled and Parallel Group Trial
This study was an exploratory phase 2 of Clinical Trial to evaluate the efficacy and safety
of Clotinab® (Abciximab) in the acute myocardial infarction patients and was designed as a
multicenter, randomized, double-blinded, placebo-controlled and parallel group study. The
objective of this phase 2 clinical trial is to evaluate correlation between infarct size and
major adverse cardiac event (MACE) of acute myocardial infarction patient, prearranged for
percutaneous coronary intervention(PCI), to measure possibility to use infarct size as a
primary efficacy test variable in phase 3 for final confirmation of safety and efficacy.
Also to determine exploratively an average variance estimation of infarct size between study
drug and placebo to confirm safety and efficacy of study drug, compared to placebo and to
use the estimation for calculating sample size for phase III clinical trial.
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