NCT03087539

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

July 1, 2016

Enrollment Period

3.6 years

First QC Date

September 9, 2016

Last Update Submit

March 16, 2017

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Correlation between the Infarct size and MACE

    To determine correlation between infarct size and MACE

    18 months

Study Arms (2)

Clotinab (Abciximab)

EXPERIMENTAL

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

Biological: Abciximab

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

AbciximabBIOLOGICAL
Also known as: Clitinab
Clotinab (Abciximab)
PlaceboBIOLOGICAL
Also known as: Plabebo
Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with acute myocardial infarction having ST segment, 1 mm or above, from at least 2 consecutive segment.
  • Patients have a plan of Percutaneous Coronary Intervention (PCI)

You may not qualify if:

  • History of myocardial infarction
  • History of hypersensitivity in aspirin, heparin, or protein drugs
  • Bleeding disorders
  • Thrombocytopenia (\<100,000unit/㎕)
  • Cardiogenic shock, chronic atrial fibrillation, and cancer
  • Patients with following criteria: Implanted pacemakers, defibrillators, intracranial metallic implants, pregnant, etc
  • Had a history of surgical operation within 4 weeks
  • Participated in other clinical trials within 2 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chonnam National University

Gwangju, Chonnam, South Korea

Location

MeSH Terms

Interventions

Abciximab

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Myungho Jeong

    Chonnam National Univ.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

March 22, 2017

Study Start

May 1, 2013

Primary Completion

December 14, 2016

Study Completion

June 1, 2017

Last Updated

March 22, 2017

Record last verified: 2016-07

Locations

KR(1)