E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037690 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 > 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) &#8805;2 (angiographically apparent thrombus that is > � the vessel diameter) 7. Pre-PCI TIMI flow grade of 0-2 |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in infarct size for the IC infusion group compared to the control as measured with cardiac MRI imaging. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Stesso farmaco con via di somministrazione diversa |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |