The study will enroll male or female ACS patients at least 18 years of age presenting with STEMI with angiographically visible thrombus (Thrombus Grade >2) who are planned to undergo emergency PCI during the acute phase of the event. MedDRA version: 9.1 Level: LLT Classification code 10037690
Conditions
Interventions
Trade Name: REOPRO*EV 1F 5ML 10MG/5ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Abciximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrati
Sponsors
Cardiologia - Azienda Ospedaliero Universitaria di Modena
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients (men or women) at least 18 years of age 2. STEMI: Presenting with ischemic chest discomfort >20 minutes and 1mm (>0.1mV) in two contiguous limb leads OR >2mm (>0.2mV) 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 > ? the vessel diameter) 7. Pre-PCI TIMI flow grade of 0-2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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/m?, 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 <30ml/min/1.73m2 should be carefully evaluated considering the gadolinium chelate-associated risk of nephrogenic systemic fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that an IntraCoronary 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 intravenous 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. It is hypothesized that infarct size in the IC infusion group will be significantly reduced as compared with the IV infusion control arm.;Secondary Objective: The median post-PCI corrected TIMI frame count (cTFC) The frequency of post PCI TIMI Grade 2/3 flow and post PCI TIMI grade 3 flow The frequency of post PCI TIMI Myocardial Perfusion Grade 3 and TIMI Myocardial Perfusion Grade 2/3ST segment resolution at 90 minutes following PCIPeak post PCI CK-MB and Troponin I levels. The frequency of sidebranch occlusion post PIC The frequency of distal cutoff/embolization post PCI The frequency of death / MI at 30 days, and the frequency of each component separately The frequency of q waves on the discharge EKG The improvement in in percent diameter stenosis before and after ClearWay deployment prior to intracoronary stent placement The above endpoints will be first analyzed among all patients, and separately for those patients in whom clot aspiration was performed prior to deployment and in those in whom aspiration was not performed prior to depolyment;Primary end point(s): Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging. | — |
Countries
Italy
Outcome results
None listed