Clinical trial NCT01404507: Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in STEMI
Official title: Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in Patients With Acute ST-segment Elevation Myocardial Infarction; ICAT Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Korean Society of Interventional Cardiology
First posted: 2011-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Index of microcirculatory resistance by fractional flow reserve (FFR)
timeFrame: 1 day
measure: Microvascular obstruction by cardiac magnetic resonance
timeFrame: 7 days
Secondary outcomes:
measure: Final TIMI flow grades
timeFrame: 1 day
measure: Final TMP grades
timeFrame: 1 day
measure: ST-segment resolution on ECG
timeFrame: 1 day
measure: Peak troponin I level
timeFrame: 5 days
measure: target vessel failure
timeFrame: 1 month
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Study officials:
affiliation: Yonsei University
name: Sung Gyun Ahn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.