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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Gp 2b 3a inhibitor; Device: aspiration thrombectomy; Other: Both use

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Wonju, Korea, Republic of, 220-701
    • Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: clotinab
Active Comparator: Aspiration thrombectomy	Device: aspiration thrombectomy; Aspiration thrombectomy via aspiration catheter; Other Names: 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 Names: Clotinab + Thrombuster II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index of microcirculatory resistance by fractional flow reserve (FFR)	Immediate measurement of Index of microcirculatory resistance	1 day
Microvascular obstruction by cardiac magnetic resonance	Microvascular obstruction by cardiac magnetic resonance	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Final TIMI flow grades	immediate measurement after successful PCI	1 day
Final TMP grades	immediate measurement of Final TMP grades	1 day
ST-segment resolution on ECG	ST-segment resolution on ECG 90-minute after PCI	1 day
Peak troponin I level	Peak troponin I level during hospitalization	5 days
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)	1 month

Collaborators and Investigators

• Sponsor: Yonsei University
• Collaborators: Korean Society of Interventional Cardiology
• Investigators: Principal Investigator: Sung Gyun Ahn, M.D., Yonsei University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: July 26, 2011
• First Submitted That Met QC Criteria: July 27, 2011
• First Posted (Estimate): July 28, 2011

Study Record Updates

• Last Update Posted (Estimate): January 16, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Acute Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Platelet Aggregation Inhibitors; Anticoagulants; Abciximab
• Other Study ID Numbers: ICAT_ver_1.2