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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

May 4, 2009
January 3, 2013
June 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00894023 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Intracoronary Abciximab With Clearway Catheter
IntraCoronary Abciximab With the ClearWay Catheter To Improve Outcomes With Lysis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Drug: Intracoronary bolus wtih ClearWay™RX catheter
    Intracoronary bolus with Clearway catheter
  • Drug: IV abciximab
    IV abciximab + infusion
  • 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
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.
 
Terminated
150
June 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients (men or women) at least 18 years of age
  2. 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
  3. Must have signed the informed consent form prior to performance of study-related procedures
  4. Native dominant and proximal culprit vessel 2.5 mm in diameter
  5. 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)
  6. Pre-PCI Thrombus score (TS) ≥ 2 (angiographically apparent thrombus that is > ½ the vessel diameter)
  7. Pre-PCI TIMI flow grade of 0-2

Exclusion Criteria:

  1. Previous PCI of the IRA
  2. Previous myocardial infarction or coronary artery bypass grafting
  3. Cardiogenic shock
  4. Three vessel disease
  5. Left main disease
  6. Severe valvular heart disease
  7. Rescue PCI (PCI following fibrinolytic administration)
  8. Facilitated PCI (PCI following fibrinolytic or GP IIb/IIIa inhibition)
  9. Contraindication to GP IIb/IIIa inhibitors such as excess bleeding risk or thrombocytopenia
  10. Current participation in another investigational trial
  11. 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
  12. 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00894023
SARD03
No
Gennaro Sardella, University of Roma La Sapienza
Gennaro Sardella
Not Provided
Not Provided
University of Roma La Sapienza
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP