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

Acute Myocardial Infarction Clinical Trial

— ICAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404507
• Other study ID #: ICAT_ver_1.2
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2011
• Last updated: January 14, 2013
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Gp 2b 3a inhibitor
bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg

Device:
• aspiration thrombectomy
Aspiration thrombectomy via aspiration catheter

Other:
• Both use
Both use of intracoronary abciximab and aspiration thrombectomy

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Wonju College of Medicine, Wonju Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Korean Society of Interventional Cardiology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index of microcirculatory resistance by fractional flow reserve (FFR)	Immediate measurement of Index of microcirculatory resistance	1 day	No
Primary	Microvascular obstruction by cardiac magnetic resonance	Microvascular obstruction by cardiac magnetic resonance	7 days	No
Secondary	Final TIMI flow grades	immediate measurement after successful PCI	1 day	No
Secondary	Final TMP grades	immediate measurement of Final TMP grades	1 day	No
Secondary	ST-segment resolution on ECG	ST-segment resolution on ECG 90-minute after PCI	1 day	No
Secondary	Peak troponin I level	Peak troponin I level during hospitalization	5 days	No
Secondary	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	Yes