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

Phase 4

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Gp 2b 3a inhibitor; Device: aspiration thrombectomy; Other: Both use

• Registration Number: NCT01404507
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-14
• Last Update Posted: 2013-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracoronary abciximab	Gp 2b 3a inhibitor	Intracoronary injection of bolus abciximab
Aspiration thrombectomy	aspiration thrombectomy	Aspiration thrombectomy
Both use	Both use	Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy

Primary Outcome Measures

Name	Time	Method
Index of microcirculatory resistance by fractional flow reserve (FFR)	1 day	Immediate measurement of Index of microcirculatory resistance
Microvascular obstruction by cardiac magnetic resonance	7 days	Microvascular obstruction by cardiac magnetic resonance

Secondary Outcome Measures

Name	Time	Method
Final TIMI flow grades	1 day	immediate measurement after successful PCI
Final TMP grades	1 day	immediate measurement of Final TMP grades
ST-segment resolution on ECG	1 day	ST-segment resolution on ECG 90-minute after PCI
Peak troponin I level	5 days	Peak troponin I level during hospitalization
target vessel failure	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)

Trial Locations

Locations (1)

Yonsei University Wonju College of Medicine, Wonju Christian Hospital; 🇰🇷 Wonju, Korea, Republic of