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

NCT ID: NCT03087539

Last Updated: 2017-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-06-30

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Clotinab (Abciximab)

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

Group Type: EXPERIMENTAL

Abciximab

Intervention Type: BIOLOGICAL

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Interventions

Abciximab

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: BIOLOGICAL

Other Intervention Names

Clitinab; Plabebo

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ISU Abxis Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Myungho Jeong

Role: PRINCIPAL_INVESTIGATOR

Chonnam National Univ.

Locations

Chonnam National University

Gwangju, Chonnam, South Korea

Countries

South Korea

Other Identifiers

ISU-CLO-201

Identifier Type: -

Identifier Source: org_study_id