Status:
TERMINATED
Intracoronary Abciximab With Clearway Catheter
Lead Sponsor:
Gennaro Sardella
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00894023
Start Date
June 1 2009
End Date
June 1 2011
Last Update
January 4 2013
Active Locations (2)
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1
Policlinico of Modena
Modena, Italy, Italy, 41124
2
Dept.of Cardiovascular Sciences,Policlinico Umberto I
Rome, Italy, 00155