Intracoronary Abciximab With Clearway Catheter

NCT00894023 | Terminated Phase 3

• 1 other identifier: SARD03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myocardial Infarction

Keywords

Patients with AMI

Outcome Measures

Primary Outcomes (1)

• Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging

  24 months

Secondary Outcomes (1)

• Angiographic outcomes of lesion, flow, and myocardial perfusion using established and validated Quantitative Coronary Angiographic Methodology

  24 months

Study Arms (2)

Abciximab

EXPERIMENTAL

IC bolus of abciximab

Drug: Intracoronary bolus wtih ClearWay™RX catheter

IV Abciximab

ACTIVE COMPARATOR

IV abciximab + infusion

Drug: IV abciximab

Interventions

Intracoronary bolus wtih ClearWay™RX catheter DRUG

Intracoronary bolus with Clearway catheter

Abciximab

IV abciximab DRUG

IV abciximab + infusion

IV Abciximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Gennaro Sardella: lead

Study Sites (2)

Policlinico of Modena

Modena, Italy, 41124, Italy

Location

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, 00155, Italy

Location

Related Publications (1)

• Sardella G, Sangiorgi GM, Mancone M, Colantonio R, Donahue M, Politi L, Bucciarelli-Ducci C, 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. doi: 10.2459/JCM.0b013e3283341c1c.

  PMID: 19918189 DERIVED

MeSH Terms

Interventions

Abciximab

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor in Cardiology

Study Record Dates

• First Submitted: May 4, 2009
• First Posted: May 6, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

IT (2)