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

This study has been completed.
Sponsor:
Collaborator:
Korean Society of Interventional Cardiology
Information provided by (Responsible Party):
Sung Gyun Ahn, Yonsei University
ClinicalTrials.gov Identifier:
NCT01404507
First received: July 26, 2011
Last updated: January 14, 2013
Last verified: January 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Yonsei University:

Primary Outcome Measures:
  • Index of microcirculatory resistance by fractional flow reserve (FFR) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Immediate measurement of Index of microcirculatory resistance

  • Microvascular obstruction by cardiac magnetic resonance [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Microvascular obstruction by cardiac magnetic resonance


Secondary Outcome Measures:
  • Final TIMI flow grades [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    immediate measurement after successful PCI

  • Final TMP grades [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    immediate measurement of Final TMP grades

  • ST-segment resolution on ECG [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    ST-segment resolution on ECG 90-minute after PCI

  • Peak troponin I level [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Peak troponin I level during hospitalization

  • target vessel failure [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Sung Gyun Ahn, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01404507     History of Changes
Other Study ID Numbers: ICAT_ver_1.2
Study First Received: July 26, 2011
Last Updated: January 14, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by 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
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on April 17, 2014