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

ISU Abxis

Status and phase: Unknown; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Biological: Placebo; Biological: Abciximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03087539

ISU-CLO-201

Details and patient eligibility

About

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

Full 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.

Enrollment: 146 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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146 participants in 2 patient groups, including a placebo group

Clotinab (Abciximab)

Experimental group

Description:

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

Treatment:

Biological: Abciximab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo