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

Phase 2

• Conditions: Acute Myocardial Infarction
• Interventions: Biological: Placebo; Biological: Abciximab

• Registration Number: NCT03087539
• Lead Sponsor: ISU Abxis Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-05
• Status Verified: 2016-07
• Study First Submitted: 2016-09-09
• Primary Completion: 2016-12-14
• Study First Submitted QC: 2017-03-16
• Last Update Submitted: 2017-03-16
• Study First Posted: 2017-03-22
• Last Update Posted: 2017-03-22
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
Clotinab (Abciximab)	Abciximab	0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours

Primary Outcome Measures

Name	Time	Method
Correlation between the Infarct size and MACE	18 months	To determine correlation between infarct size and MACE

Trial Locations

Locations (1)

Chonnam National University; 🇰🇷 Gwangju, Chonnam, Korea, Republic of