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

NCT01404507 | Completed Phase 4 DMC

• 1 other identifier: ICAT_ver_1.2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Final TIMI flow grades

  1 day

• Final TMP grades

  1 day

• ST-segment resolution on ECG

  1 day

• Peak troponin I level

  5 days

• target vessel failure

  1 month

Study Arms (3)

Intracoronary abciximab

ACTIVE COMPARATOR

Intracoronary injection of bolus abciximab

Drug: Gp 2b 3a inhibitor

Aspiration thrombectomy

ACTIVE COMPARATOR

Aspiration thrombectomy

Device: aspiration thrombectomy

Both use

ACTIVE COMPARATOR

Both use of intracoronary injection of bolus abciximab and aspiration thrombectomy

Other: Both use

Interventions

Gp 2b 3a inhibitor DRUG

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

Also known as: clotinab

Intracoronary abciximab

aspiration thrombectomy DEVICE

Aspiration thrombectomy via aspiration catheter

Also known as: Thrombuster II

Aspiration thrombectomy

Both use OTHER

Both use of intracoronary abciximab and aspiration thrombectomy

Also known as: Clotinab + Thrombuster II

Both use

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead
• Korean Society of Interventional Cardiology: collaborator

Study Sites (1)

Yonsei University Wonju College of Medicine, Wonju Christian Hospital

Wŏnju, 220-701, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24719126 DERIVED

MeSH Terms

Interventions

Abciximab; Thrombectomy

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sung Gyun Ahn, M.D.

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 28, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

KR (1)