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Acute Myocardial InfarctionPhase 2NCT03087539

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

A Phase 2 study testing Abciximab in people with Acute Myocardial Infarction, run by ISU Abxis Co., Ltd. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Abciximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
146 participants
Where
1 siteSouth Korea
Study dates
May 2013to Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Chonnam National University

    Gwangju, Chonnam

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
Abciximab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbciximabBiological

    Also called Clitinab

  • PlaceboBiological

    Also called Plabebo

Study groups in NCT03087539
Study groupRoleWhat they receive
Clotinab (Abciximab)Experimental0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
Receives: Biological: Abciximab
PlaceboPlacebo comparator0.25 mg/kg bolus prior to PCI and then 10 ug/kg/min continuous infusion for 12 hours
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between the Infarct size and MACE

    To determine correlation between infarct size and MACE

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2017
  2. Study startMay 2013
  3. Primary completion14 Dec 2016
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03087539
Sponsor's protocol ID
ISU-CLO-201
Status last verified
Jul 2016
First submitted
9 Sep 2016
Last updated
22 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: No comment

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abciximab in people with Acute Myocardial Infarction, run by ISU Abxis Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between the Infarct size and MACE (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03087539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.

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