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

NCT ID: NCT01404507

Last Updated: 2013-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-02-29

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.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intracoronary abciximab

Intracoronary injection of bolus abciximab

Group Type: ACTIVE_COMPARATOR

Gp 2b 3a inhibitor

Intervention Type: DRUG

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

Aspiration thrombectomy

Aspiration thrombectomy

Group Type: ACTIVE_COMPARATOR

aspiration thrombectomy

Intervention Type: DEVICE

Aspiration thrombectomy via aspiration catheter

Both use

Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy

Group Type: ACTIVE_COMPARATOR

Both use

Intervention Type: OTHER

Both use of intracoronary abciximab and aspiration thrombectomy

Interventions

Gp 2b 3a inhibitor

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

Intervention Type: DRUG

aspiration thrombectomy

Aspiration thrombectomy via aspiration catheter

Intervention Type: DEVICE

Both use

Both use of intracoronary abciximab and aspiration thrombectomy

Intervention Type: OTHER

Other Intervention Names

clotinab; Thrombuster II; Clotinab + Thrombuster II

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korean Society of Interventional Cardiology

UNKNOWN

Sponsor Role: collaborator

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Sung Gyun Ahn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung Gyun Ahn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yonsei University

Locations

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 24719126 (View on PubMed)

Other Identifiers

ICAT_ver_1.2

Identifier Type: -

Identifier Source: org_study_id