NCT01383785

Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab

Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Hospital Virgen de la Salud · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aims: (to prove that) The distal injection of IIb IIIa platelet receptor blocker to the thrombus occlusion is better than normal injection during primary percutaneous intervention (PCI) for the treatment of acute myocardial infarction. Using this modification of injection method the investigators can achieve less microvascular damage and a reduction of the infarct size with a significant improvement of the outcome at six months.

Detailed description

There are some evidence about the utilization of aspiration catheter (Indication class IIb with level of evidence B in European Guidelines) and intravenous abciximab (indication Class IIa an level of evidence A in European Guidelines) in primary PTCA. Direct intracoronary injection of abciximab get smaller infarct size than intravenous injection. The hypothesis of our study are that direct distal injection of abciximab by aspiration catheter will be better than proximal intracoronary injection with reduction in infarct size and microvascular damage quantified by Magnetic resonance (MR) and 6 months mortality.

Conditions

• Myocardial Infarction
• Occlusive Thrombus

Interventions

Type	Name	Description
OTHER	Intracoronary direct injection	Abciximab bolus dosage: 0,125 mg/kg. Group A: Intracoronary full bolus dose of abciximab proximal to thrombus occlusion. The investigators inject the bolus of abciximab by catheter guide before cross the occlusion. This in the normal way in study' laboratory.
OTHER	Intracoronary and distal injection by aspiration device	Abciximab bolus dosage: 0,125 mg/kg. Group B: Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter. The investigators inject half of the dose like group A and the other half like group C.
OTHER	Intracoronary distal injection by aspiration catheter device	Abciximab bolus dosage: 0,125 mg/kg. Group C: Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter. The investigators inject the bolus after cross the occlusion using an aspiration catheter.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-07-01
• Completion: 2012-12-01
• First posted: 2011-06-28
• Last updated: 2012-02-22

Locations

1 site across 1 country: Spain