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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03087539

Enrollment

146

Registered

2017-03-22

Start date

2013-05-31

Completion date

2017-06-30

Last updated

2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

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.

Interventions

BIOLOGICALAbciximab

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026