Intracoronary Abciximab With Clearway Catheter (IC-CLEARLY)

This study has been terminated.

(the study was stopped because the sample size was very difficult to achieve.)

Sponsor:

Information provided by (Responsible Party):

Gennaro Sardella, University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT00894023

First received: May 4, 2009

Last updated: January 3, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 4, 2009
Last Updated Date	January 3, 2013
Start Date ^ICMJE	June 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 5, 2009)	Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00894023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 5, 2009)	Angiographic outcomes of lesion, flow, and myocardial perfusion using established and validated Quantitative Coronary Angiographic Methodology [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intracoronary Abciximab With Clearway Catheter
Official Title ^ICMJE	IntraCoronary Abciximab With the ClearWay Catheter To Improve Outcomes With Lysis
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Acute Myocardial Infarction
Intervention ^ICMJE	Drug: Intracoronary bolus wtih ClearWay™RX catheter Intracoronary bolus with Clearway catheter Drug: IV abciximab IV abciximab + infusion
Study Arm (s)	Experimental: Abciximab IC bolus of abciximab Intervention: Drug: Intracoronary bolus wtih ClearWay™RX catheter Active Comparator: IV Abciximab IV abciximab + infusion Intervention: Drug: IV abciximab
Publications *	Sardella G, Sangiorgi GM, Mancone M, Colantonio R, Donahue M, Politi L, Ducci CB, Carbone I, Francone M, Ligabue G, Fiocchi F, Di Roma A, Benedetti G, Lucisano L, Stio RE, Agati L, Modena MG, Genuini I, Fedele F, Gibson M. A multicenter randomized study to evaluate intracoronary abciximab with the ClearWay catheter to improve outcomes with Lysis (IC ClearLy): trial study design and rationale. J Cardiovasc Med (Hagerstown). 2010 Jul;11(7):529-35.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	150
Completion Date	June 2011
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients (men or women) at least 18 years of age STEMI: Presenting with ischemic chest discomfort > 20 minutes and <6 hours of duration suggestive of acute myocardial infarction AND ST elevation > 1 mm (> 0.1 mV) in two contiguous limb leads OR > 2 mm (> 0.2 mV) in two contiguous precordial leads Must have signed the informed consent form prior to performance of study-related procedures Native dominant and proximal culprit vessel 2.5 mm in diameter Angiographically identifiable thrombus (presence of a filling defect within the coronary lumen surrounded by contrast medium observed in multiple projections, without calcium within the filling defect, or persistence of contrast medium within the coronary lumen) Pre-PCI Thrombus score (TS) ≥ 2 (angiographically apparent thrombus that is > ½ the vessel diameter) Pre-PCI TIMI flow grade of 0-2 Exclusion Criteria: Previous PCI of the IRA Previous myocardial infarction or coronary artery bypass grafting Cardiogenic shock Three vessel disease Left main disease Severe valvular heart disease Rescue PCI (PCI following fibrinolytic administration) Facilitated PCI (PCI following fibrinolytic or GP IIb/IIIa inhibition) Contraindication to GP IIb/IIIa inhibitors such as excess bleeding risk or thrombocytopenia Current participation in another investigational trial Exclusion criteria for the MRI imaging include implanted pacemakers, defibrillators, or metallic intracranial implants, severe claustrophobia, BMI > 35 kg/m², atrial fibrillation or known not well controlled extrasystoles (bad images), or allergy to gadolinium-DTPA Enrolment of patients with an estimated glomerular filtration rate < 30 ml/min/1.73 m2 should be carefully evaluated considering the gadolinium chelate-associated risk of nephrogenic systemic fibrosis
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT00894023
Other Study ID Numbers ^ICMJE	SARD03
Has Data Monitoring Committee	No
Responsible Party	Gennaro Sardella, University of Roma La Sapienza
Study Sponsor ^ICMJE	Gennaro Sardella
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Roma La Sapienza
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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