Status:
COMPLETED
Efficacy of Combination of IntraCoronary Bolus Abciximab and Aspiration Thrombectomy in STEMI
Lead Sponsor:
Yonsei University
Collaborating Sponsors:
Korean Society of Interventional Cardiology
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 incre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01404507
Start Date
December 1 2010
End Date
February 1 2012
Last Update
January 16 2013
Active Locations (1)
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1
Yonsei University Wonju College of Medicine, Wonju Christian Hospital
Wŏnju, South Korea, 220-701