Intracoronary Abciximab With Clearway Catheter (IC-CLEARLY)
Background: Percutaneous coronary intervention (PCI) is a highly effective therapy for acute ST-elevation myocardial infarction (STEMI). Adjunctive therapy with glycoprotein (GP) IIb/IIIa inhibitor can result in increased patency and improved outcomes in STEMI patients, with thrombus, undergoing PCI. The investigation of novel dosing and delivery strategies of this therapy may help to further improve outcomes.
Study design: Intracoronary Abciximab With Clearway Catheter trial is a randomized, open-label, multicenter, trial to evaluate the effect of an intracoronary (IC) bolus dose of abciximab delivered using the ClearWay™RX catheter versus an intravenous bolus (IV) of abciximab for STEMI with angiographically visible thrombus (Thrombus Grade > 2). All patients in both arms will receive intravenous abciximab infusion following the PCI for 12 hours per standard practice. A total of 150 patients will be randomized 1:1 to treatment of the culprit artery with IC abciximab (75 subjects) or IV abciximab (75 subjects) in addition to an infusion regimen of abciximab administered intravenously and initiated following PCI. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on Cardiac Magnetic Resonance (CMR). Clinical outcomes will be assessed for each subject through hospital discharge and at 30 day follow-up.
Sample size: The number of patients included in this study was based on the estimation of the sample size needed to identify a statistically significant difference of the primary end-points between the two groups. The investigators estimated that 75 patients would be required in each study group to have a power of 80% to detect an absolute difference in the infarct size resolution of 15% with a two-sided alpha value of 0.05.
Conclusion: The purpose of this study is to demonstrate that an IC bolus of abciximab delivered with the ClearWay™RX catheter added to a post-PCI intravenous infusion regimen of abciximab will result in significant additional clot resolution in vivo when compared with an IV bolus of abciximab when added to a post PCI intravenous infusion regimen of abciximab. The primary endpoint chosen to evaluate this hypothesis is infarct size as assessed on CMR.
|Acute Myocardial Infarction||Drug: Intracoronary bolus wtih ClearWay™RX catheter Drug: IV abciximab||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||IntraCoronary Abciximab With the ClearWay Catheter To Improve Outcomes With Lysis|
- Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging [ Time Frame: 24 months ]
- Angiographic outcomes of lesion, flow, and myocardial perfusion using established and validated Quantitative Coronary Angiographic Methodology [ Time Frame: 24 months ]
|Study Start Date:||June 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
IC bolus of abciximab
Drug: Intracoronary bolus wtih ClearWay™RX catheter
Intracoronary bolus with Clearway catheter
Active Comparator: IV Abciximab
IV abciximab + infusion
Drug: IV abciximab
IV abciximab + infusion
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894023
|Policlinico of Modena|
|Modena, Italy, 41124|
|Dept.of Cardiovascular Sciences,Policlinico Umberto I|
|Rome, Italy, 00155|