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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gp 2b 3a inhibitor
aspiration thrombectomy
Both use
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Acute Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Intracoronary abciximab

Aspiration thrombectomy

Both use

Arm Description

Intracoronary injection of bolus abciximab

Aspiration thrombectomy

Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy

Outcomes

Primary Outcome Measures

Index of microcirculatory resistance by fractional flow reserve (FFR)
Immediate measurement of Index of microcirculatory resistance
Microvascular obstruction by cardiac magnetic resonance
Microvascular obstruction by cardiac magnetic resonance

Secondary Outcome Measures

Final TIMI flow grades
immediate measurement after successful PCI
Final TMP grades
immediate measurement of Final TMP grades
ST-segment resolution on ECG
ST-segment resolution on ECG 90-minute after PCI
Peak troponin I level
Peak troponin I level during hospitalization
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)

Full Information

First Posted
July 26, 2011
Last Updated
January 14, 2013
Sponsor
Yonsei University
Collaborators
Korean Society of Interventional Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT01404507
Brief Title
Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in STEMI
Acronym
ICAT
Official Title
Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in Patients With Acute ST-segment Elevation Myocardial Infarction; ICAT Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
Collaborators
Korean Society of Interventional Cardiology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intracoronary abciximab
Arm Type
Active Comparator
Arm Description
Intracoronary injection of bolus abciximab
Arm Title
Aspiration thrombectomy
Arm Type
Active Comparator
Arm Description
Aspiration thrombectomy
Arm Title
Both use
Arm Type
Active Comparator
Arm Description
Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy
Intervention Type
Drug
Intervention Name(s)
Gp 2b 3a inhibitor
Other Intervention Name(s)
clotinab
Intervention Description
bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg
Intervention Type
Device
Intervention Name(s)
aspiration thrombectomy
Other Intervention Name(s)
Thrombuster II
Intervention Description
Aspiration thrombectomy via aspiration catheter
Intervention Type
Other
Intervention Name(s)
Both use
Other Intervention Name(s)
Clotinab + Thrombuster II
Intervention Description
Both use of intracoronary abciximab and aspiration thrombectomy
Primary Outcome Measure Information:
Title
Index of microcirculatory resistance by fractional flow reserve (FFR)
Description
Immediate measurement of Index of microcirculatory resistance
Time Frame
1 day
Title
Microvascular obstruction by cardiac magnetic resonance
Description
Microvascular obstruction by cardiac magnetic resonance
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Final TIMI flow grades
Description
immediate measurement after successful PCI
Time Frame
1 day
Title
Final TMP grades
Description
immediate measurement of Final TMP grades
Time Frame
1 day
Title
ST-segment resolution on ECG
Description
ST-segment resolution on ECG 90-minute after PCI
Time Frame
1 day
Title
Peak troponin I level
Description
Peak troponin I level during hospitalization
Time Frame
5 days
Title
target vessel failure
Description
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)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Gyun Ahn, M.D.
Organizational Affiliation
Yonsei University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24719126
Citation
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.
Results Reference
derived

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

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