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

Acute Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03087539
• Other study ID #: ISU-CLO-201
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 9, 2016
• Last updated: March 16, 2017
• Start date: May 2013
• Est. completion date: June 2017

Study information

• Verified date: July 2016
• Source: ISU Abxis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 146
• Est. completion date: June 2017
• Est. primary completion date: December 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Biological:
• Abciximab

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University	Gwangju	Chonnam

Sponsors (1)

Lead Sponsor	Collaborator
ISU Abxis Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the Infarct size and MACE	To determine correlation between infarct size and MACE	18 months