An interventional study of abciximab and abciximab in ST-Elevation Myocardial Infarction, sponsored by University Medical Center Groningen. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-08.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Treatment
The primary objective of this study is to investigate whether intracoronary bolus administration of abciximab is superior to intravenous bolus administration in improving myocardial perfusion in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.
The contemporary management of ST-segment elevation myocardial infarction (STEMI) consists of primary percutaneous coronary intervention (PCI) including thrombus aspiration and stenting. There is, however, still a high incidence of impaired post-procedural myocardial perfusion, which is associated with poorer clinical outcomes. Intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor abciximab during primary PCI plays an important role in the treatment of patients with STEMI. With higher local drug concentrations, abciximab may have additional anti-platelet, anti-thrombotic and anti-inflammatory features. These possible benefits may be obtained by intracoronary (IC) administration of abciximab. Recent small- to medium-scaled studies have suggested that IC administration of abciximab instead of the (IV) route is associated with improved post-procedural myocardial perfusion and a clinically relevant reduction of major adverse cardiac events.
Because of the limited number of patients included in these studies, a larger randomized clinical trial is needed to evaluate the effect of IC abciximab in patients with STEMI. Furthermore, the combined strategy of PCI with thrombus aspiration and IC use of abciximab has not been investigated.
Therefore, the investigators intend to evaluate the effect of IC bolus administration of abciximab compared to IV bolus administration on post-procedural myocardial perfusion as assessed by the extent of ST-segment elevation resolution in patients with STEMI undergoing primary PCI. The study is a single-center, prospective, randomized trial with blinded evaluation of endpoints.
688 studies on the registry are indexed under ST Elevation Myocardial Infarction; 184 are open to participants now.
This study's enrollment of 534 is above the median of 194 across 439 interventional studies indexed under ST Elevation Myocardial Infarction.
Browse ST Elevation Myocardial Infarction studies →University Medical Center Groningen is the lead sponsor of 625 studies on the registry; 174 are open to participants now.
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a diagnosis of STEMI defined by
Exclusion Criteria:
intracoronary administration of abciximab (0.25 mg/kg body weight)
Drug: abciximab
intravenous administration of abciximab (0.25 mg/kg body weight)
Drug: abciximab
incidence of ST-segment resolution >70%
Time frame: 30 to 60 minutes post-PCI
Bleeding complications
Time frame: in-hospital
Thrombolysis In Myocardial Infarction (TIMI) flow
Time frame: post-PCI
Myocardial Blush Grade (MBG)
Time frame: post-PCI
Incidence of distal embolization
Time frame: post-PCI
persistent residual ST-segment deviation
Time frame: 30 to 60 minutes post-PCI
enzymatic infarct size
Time frame: in-hospital
Major Adverse Cardiac Events (MACE)
Time frame: 30 days
The record gives a start of Sep 2008, a primary completion of May 2010 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Abciximab
ST Elevation Myocardial Infarction →
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