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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in Patients With Acute ST-segment Elevation Myocardial Infarction; ICAT Trial

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Gp 2b 3a inhibitor
* Device: aspiration thrombectomy
* Other: Both use


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intracoronary abciximab<br>Intracoronary injection of bolus abciximab | Drug: Gp 2b 3a inhibitor<br>* bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg<br>* Other names: clotinab;|
| Active Comparator: Aspiration thrombectomy<br>Aspiration thrombectomy | Device: aspiration thrombectomy<br>* Aspiration thrombectomy via aspiration catheter<br>* Other names: Thrombuster II;|
| Active Comparator: Both use<br>Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy | Other: Both use<br>* Both use of intracoronary abciximab and aspiration thrombectomy<br>* Other names: Clotinab + Thrombuster II;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myocardial Infarction