Trial | NCT01404507  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    abciximab ...

  • Study Participants

    40
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 Started
Dec 31
2010
Primary Completion
Feb 29
2012
Study Completion
Feb 29
2012
Last Update
Jan 16
2013
Estimate

Drug Gp 2b 3a inhibitor

bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg

  • Other names: clotinab

Device aspiration thrombectomy

Aspiration thrombectomy via aspiration catheter

  • Other names: Thrombuster II

Other Both use

Both use of intracoronary abciximab and aspiration thrombectomy

  • Other names: Clotinab + Thrombuster II

Intracoronary abciximab Active Comparator

Intracoronary injection of bolus abciximab

Aspiration thrombectomy Active Comparator

Aspiration thrombectomy

Both use Active Comparator

Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy

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.
No Results Posted