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Acute Myocardial InfarctionPhase 4ICATNCT01404507

Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in STEMI

A Phase 4 study testing Gp 2b 3a inhibitor, aspiration thrombectomy and Both use in people with Acute Myocardial Infarction, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to potential increase of bleeding. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Gp 2b 3a inhibitor, aspiration thrombectomy and Both use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
Dec 2010to Feb 2012
Phase
Phase 4
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be between at least 18 years of age and less than 80 years of age.
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving intracoronary abciximab and/or aspiration thrombectomy.
  • He/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  • Subject must have evidence of acute ST-segment elevation myocardial infarction with TIMI 0 or 1 flow, or visible thrombi (thrombus grade ≥ 3)
  • Target lesion(s) must be located in a native coronary artery in the proximal to mid segment with estimated reference diameter of ≥ 2.5 mm and ≤ 4.0 mm.
  • Target lesion(s) must be amenable for percutaneous coronary intervention.

Who cannot join

  • The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Abciximab, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.)
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or refuses blood transfusions.
  • Baseline hemogram with Hb<10g/dL or PLT count <100,000/μL
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
  • Patients with severe LV systolic dysfunction (LVEF<25%) or in cardiogenic shock
  • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Wonju College of Medicine, Wonju Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

About this study

Official title: Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in Patients With Acute ST-segment Elevation Myocardial Infarction; ICAT Trial

The routine use of glycoprotein (Gp) IIb-IIIa inhibitor such as abciximab is not recommended by current ACC/AHA guideline (Class IIb, level of evidence of A). This may be partly due to potential increase of bleeding. Compared bolus injection followed by continuous infusion of Gp IIb-IIIa inhibitor, single bolus administration was proposed to decrease bleeding complication while maintaining decrease ischemic events. It was also reported that direct intracoronary injection of abciximab might be superior to intravenous injection regarding myocardial perfusion.

Aspiration thrombectomy is regarded as important adjunctive therapy in the treatment of acute ST-elevation myocardial infarction (IIa, level of evidence of B). We hypothesized that combination of intracoronary abciximab bolus injection and aspiration thrombectomy might enhance adequate myocardial perfusion in patient with acute ST-elevation myocardial infarction. We will determine whether combination of intracoronary abciximab injection and aspiration thrombectomy is superior to each treatment only in terms of myocardial perfusion through index of microcirculatory resistance and cardiac magnetic resonance imaging.

Being tested
Gp 2b 3a inhibitor, aspiration thrombectomy, Both use
Keywords
Acute Myocardial Infarction

What participants receive

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

  • Gp 2b 3a inhibitorDrug

    Also called clotinab

    bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg

  • aspiration thrombectomyDevice

    Also called Thrombuster II

    Aspiration thrombectomy via aspiration catheter

  • Both useOther

    Also called Clotinab + Thrombuster II

    Both use of intracoronary abciximab and aspiration thrombectomy

Study groups in NCT01404507
Study groupRoleWhat they receive
Intracoronary abciximabActive comparatorIntracoronary injection of bolus abciximab
Receives: Drug: Gp 2b 3a inhibitor
Aspiration thrombectomyActive comparatorAspiration thrombectomy
Receives: Device: aspiration thrombectomy
Both useActive comparatorBoth use of intracoronary injection of bolus abciximab and aspiration thrombectomy
Receives: Other: Both use

What is being measured

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

  1. Index of microcirculatory resistance by fractional flow reserve (FFR)

    Immediate measurement of Index of microcirculatory resistance

    Measured: 1 day

  2. Microvascular obstruction by cardiac magnetic resonance

    Microvascular obstruction by cardiac magnetic resonance

    Measured: 7 days

Secondary outcomes (5)

  1. Final TIMI flow grades

    immediate measurement after successful PCI

    Measured: 1 day

  2. Final TMP grades

    immediate measurement of Final TMP grades

    Measured: 1 day

  3. ST-segment resolution on ECG

    ST-segment resolution on ECG 90-minute after PCI

    Measured: 1 day

  4. Peak troponin I level

    Peak troponin I level during hospitalization

    Measured: 5 days

  5. target vessel failure

    1-month target vessel failure defined as a composite of death from cardiac causes, any MI (not clearly attributable to a non-target vessel), or clinically indicated target vessel revascularization (TLR)

    Measured: 1 month

Timeline

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

  1. First posted28 Jul 2011 (estimated)
  2. Study startDec 2010
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01404507
Sponsor's protocol ID
ICAT_ver_1.2
Acronym
ICAT
Status last verified
Jan 2013
First submitted
26 Jul 2011
Last updated
16 Jan 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Ahn SG, Lee SH, Lee JH, Lee JW, Youn YJ, Ahn MS, Kim JY, Yoo BS, Yoon J, Choe KH, Tahk SJ. Efficacy of combination treatment with intracoronary abciximab and aspiration thrombectomy on myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary coronary stenting. Yonsei Med J. 2014 May;55(3):606-16. doi: 10.3349/ymj.2014.55.3.606. Epub 2014 Apr 1.

    PubMed 24719126

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gp 2b 3a inhibitor, aspiration thrombectomy and Both use in people with Acute Myocardial Infarction, run by Yonsei University 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 6 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: finished, as of the sponsor's last update on 16 Jan 2013. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Index of microcirculatory resistance by fractional flow reserve (FFR) (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT01404507, which also lists 1 linked publication.

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 16 Jan 2013.

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