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Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in STEMI (ICAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404507
First Posted: July 28, 2011
Last Update Posted: January 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Korean Society of Interventional Cardiology
Information provided by (Responsible Party):
Sung Gyun Ahn, Yonsei University
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction Drug: Gp 2b 3a inhibitor Device: aspiration thrombectomy Other: Both use Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in Patients With Acute ST-segment Elevation Myocardial Infarction; ICAT Trial

Resource links provided by NLM:


Further study details as provided by Sung Gyun Ahn, Yonsei University:

Primary Outcome Measures:
  • Index of microcirculatory resistance by fractional flow reserve (FFR) [ Time Frame: 1 day ]
    Immediate measurement of Index of microcirculatory resistance

  • Microvascular obstruction by cardiac magnetic resonance [ Time Frame: 7 days ]
    Microvascular obstruction by cardiac magnetic resonance


Secondary Outcome Measures:
  • Final TIMI flow grades [ Time Frame: 1 day ]
    immediate measurement after successful PCI

  • Final TMP grades [ Time Frame: 1 day ]
    immediate measurement of Final TMP grades

  • ST-segment resolution on ECG [ Time Frame: 1 day ]
    ST-segment resolution on ECG 90-minute after PCI

  • Peak troponin I level [ Time Frame: 5 days ]
    Peak troponin I level during hospitalization

  • 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)


Enrollment: 40
Study Start Date: December 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intracoronary abciximab
Intracoronary injection of bolus abciximab
Drug: Gp 2b 3a inhibitor
bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg
Other Name: clotinab
Active Comparator: Aspiration thrombectomy
Aspiration thrombectomy
Device: aspiration thrombectomy
Aspiration thrombectomy via aspiration catheter
Other Name: Thrombuster II
Active Comparator: Both use
Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy
Other: Both use
Both use of intracoronary abciximab and aspiration thrombectomy
Other Name: Clotinab + Thrombuster II

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404507


Locations
Korea, Republic of
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Wonju, Korea, Republic of, 220-701
Sponsors and Collaborators
Yonsei University
Korean Society of Interventional Cardiology
Investigators
Principal Investigator: Sung Gyun Ahn, M.D. Yonsei University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sung Gyun Ahn, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01404507     History of Changes
Other Study ID Numbers: ICAT_ver_1.2
First Submitted: July 26, 2011
First Posted: July 28, 2011
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by Sung Gyun Ahn, Yonsei University:
Acute Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Anticoagulants
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs