Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab (TOLEDO1)

Hospital Virgen de la Salud

Status and phase: Unknown; Phase 4

Conditions: Myocardial Infarction; Occlusive Thrombus

Treatments: Other: Intracoronary direct injection; Other: Intracoronary and distal injection by aspiration device; Other: Intracoronary distal injection by aspiration catheter device

Study type: Interventional

Funder types: Other

Identifiers

NCT01383785

PI-2008/52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 3 patient groups

GROUP A

Active Comparator group

Description:

Intracoronary full bolus dose of abciximab proximal to thrombus occlusion

Treatment:

Other: Intracoronary direct injection

GROUP B

Experimental group

Description:

Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter

Treatment:

Other: Intracoronary and distal injection by aspiration device

GROUP C

Experimental group

Description:

Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter

Treatment:

Other: Intracoronary distal injection by aspiration catheter device