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

Phase 4

• Conditions: Myocardial Infarction; Occlusive Thrombus
• Interventions: Other: Intracoronary direct injection; Other: Intracoronary and distal injection by aspiration device; Other: Intracoronary distal injection by aspiration catheter device

• Registration Number: NCT01383785
• Lead Sponsor: Hospital Virgen de la Salud

Brief 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-06-22
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-20
• Last Update Posted: 2012-02-22
• Primary Completion: 2012-07
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Myocardial infarction patients between 3 and 12 hours after symptoms onset

Exclusion Criteria

• Hemodynamic instability
• TIMI flow 2 or 3
• Life expectance less than 6 months
• Contraindication to AAS, clopidogrel or abciximab
• Severe tortuosity of occluded vessel

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP A	Intracoronary direct injection	Intracoronary full bolus dose of abciximab proximal to thrombus occlusion
GROUP B	Intracoronary and distal injection by aspiration device	Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter
GROUP C	Intracoronary distal injection by aspiration catheter device	Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter

Primary Outcome Measures

Name	Time	Method
Infarct size	Between 2 and 9 days after primary ptca	Infarct size quantified by MR

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	6 months	Cardiac mortality, reinfarction, new revascularization, and stroke

Trial Locations

Locations (1)

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain