Exploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Biological: Abciximab
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients with acute myocardial infarction having ST segment, 1 mm or above, from at least 2 consecutive segment. Patients have a plan of Percutaneous Coronary Intervention (PCI) Exclusion criteria History of myocardial infarction History of hypersensitivity in aspirin, heparin, or protein drugs Bleeding disorders Thrombocytopenia (<100,000unit/㎕) Cardiogenic shock, chronic atrial fibrillation, and cancer Patients with following criteria: Implanted pacemakers, defibrillators, intracranial metallic implants, pregnant, etc Had a history of surgical operation within 4 weeks Participated in other clinical trials within 2 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clotinab (Abciximab)<br>0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours | Biological: Abciximab<br> <br> * Other names: Clitinab;|
| Placebo Comparator: Placebo<br>0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours | Biological: Placebo<br> <br> * Other names: Plabebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the Infarct size and MACE | To determine correlation between infarct size and MACE | 18 months |