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

March 16, 2017 updated by: ISU Abxis Co., Ltd.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

146

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chonnam
      • Gwangju, Chonnam, Korea, Republic of
        • Chonnam National University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ISU Abxis Co., Ltd.

Investigators

  • Principal Investigator: Myungho Jeong, Chonnam National Univ.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

December 14, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISU-CLO-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

No comment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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