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Completed

NCT Number: NCT01404507

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Wŏnju, 220-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Gp 2b 3a inhibitor

Drug

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

Other names: clotinab

Aspiration thrombectomy

Device

Aspiration thrombectomy via aspiration catheter

Other names: Thrombuster II

Both use

Other

Both use of intracoronary abciximab and aspiration thrombectomy

Other names: Clotinab + Thrombuster II

Primary outcomes

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

    Time frame: 1 day

    Immediate measurement of Index of microcirculatory resistance

  2. Microvascular obstruction by cardiac magnetic resonance

    Time frame: 7 days

    Microvascular obstruction by cardiac magnetic resonance

Secondary outcomes

  1. Final TIMI flow grades

    Time frame: 1 day

    immediate measurement after successful PCI

  2. Final TMP grades

    Time frame: 1 day

    immediate measurement of Final TMP grades

  3. ST-segment resolution on ECG

    Time frame: 1 day

    ST-segment resolution on ECG 90-minute after PCI

  4. Peak troponin I level

    Time frame: 5 days

    Peak troponin I level during hospitalization

  5. target vessel failure

    Time frame: 1 month

    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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Korean Society of Interventional Cardiology

Registry information

Official study title

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

Acronym: ICAT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 28, 2011
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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