Back to resultsExploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Abciximab
Placebo
Sponsored by
About this trial
This is an interventional other trial for Acute Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Chonnam National University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Clotinab (Abciximab)
Placebo
Arm Description
0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
Outcomes
Primary Outcome Measures
Correlation between the Infarct size and MACE
To determine correlation between infarct size and MACE
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03087539
Brief Title
Exploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 14, 2016 (Actual)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ISU Abxis Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clotinab (Abciximab)
Arm Type
Experimental
Arm Description
0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
Intervention Type
Biological
Intervention Name(s)
Abciximab
Other Intervention Name(s)
Clitinab
Intervention Type
Biological
Intervention Name(s)
Placebo
Other Intervention Name(s)
Plabebo
Primary Outcome Measure Information:
Title
Correlation between the Infarct size and MACE
Description
To determine correlation between infarct size and MACE
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myungho Jeong
Organizational Affiliation
Chonnam National Univ.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonnam National University
City
Gwangju
State/Province
Chonnam
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
No comment
Learn more about this trial
Exploratory P2 Trial to Evaluate Efficacy and Safety of Clotinab® (Abciximab) in Acute MI Patients
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