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
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Intracoronary bolus wtih ClearWay™RX catheter
Drug: IV abciximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IntraCoronary Abciximab With the ClearWay Catheter To Improve Outcomes With Lysis

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abciximab
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894023

Locations
Italy
Policlinico of Modena
Modena, Italy, 41124
Dept.of Cardiovascular Sciences,Policlinico Umberto I
Rome, Italy, 00155
Sponsors and Collaborators
Gennaro Sardella
  More Information

No publications provided by University of Roma La Sapienza

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT00894023     History of Changes
Other Study ID Numbers: SARD03
Study First Received: May 4, 2009
Last Updated: January 3, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Patients with AMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014