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

Sponsor
ISU Abxis Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03087539
Collaborator
(none)
146
Enrollment
1
Location
2
Arms
49
Duration (Months)
3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Abciximab
  • Biological: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
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 Start Date :
May 1, 2013
Actual Primary Completion Date :
Dec 14, 2016
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Clotinab (Abciximab)

0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours

Biological: Abciximab
Other Names:
  • Clitinab

    		•
    Placebo Comparator: Placebo

    0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours

    Biological: Placebo
    Other Names:
  • Plabebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between the Infarct size and MACE [18 months]

      To determine correlation between infarct size and MACE

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion criteria

    1. Patients with acute myocardial infarction having ST segment, 1 mm or above, from at least 2 consecutive segment.

    2. Patients have a plan of Percutaneous Coronary Intervention (PCI)

    Exclusion criteria

    1. History of myocardial infarction

    2. History of hypersensitivity in aspirin, heparin, or protein drugs

    3. Bleeding disorders

    4. Thrombocytopenia (<100,000unit/㎕)

    5. Cardiogenic shock, chronic atrial fibrillation, and cancer

    6. Patients with following criteria: Implanted pacemakers, defibrillators, intracranial metallic implants, pregnant, etc

    7. Had a history of surgical operation within 4 weeks

    8. Participated in other clinical trials within 2 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chonnam National University Gwangju Chonnam Korea, Republic of

    Sponsors and Collaborators

    • ISU Abxis Co., Ltd.

    Investigators

    • Principal Investigator: Myungho Jeong, Chonnam National Univ.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ISU Abxis Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03087539
    Other Study ID Numbers:
    • ISU-CLO-201
    First Posted:
    Mar 22, 2017
    Last Update Posted:
    Mar 22, 2017
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Abciximab

    Study Results

    No Results Posted as of Mar 22, 2017