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

Myocardial Infarction Clinical Trial

— TOLEDO1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01383785
• Other study ID #: PI-2008/52
• Status: Recruiting
• Phase: Phase 4
• First received: June 22, 2011
• Last updated: February 20, 2012
• Start date: November 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: Hospital Virgen de la Salud
• Contact: Jose Moreu, MD,PhD
• Phone: +34 925 269 188
• Email: jmoreu[@]sescam.jccm.es
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myocardial Infarction
• Occlusive Thrombus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Virgen de la Salud	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Virgen de la Salud

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Nijveldt R, Beek AM, Hirsch A, Stoel MG, Hofman MB, Umans VA, Algra PR, Twisk JW, van Rossum AC. Functional recovery after acute myocardial infarction: comparison between angiography, electrocardiography, and cardiovascular magnetic resonance measures of microvascular injury. J Am Coll Cardiol. 2008 Jul 15;52(3):181-9. doi: 10.1016/j.jacc.2008.04.006. — View Citation

Svilaas T, Vlaar PJ, van der Horst IC, Diercks GF, de Smet BJ, van den Heuvel AF, Anthonio RL, Jessurun GA, Tan ES, Suurmeijer AJ, Zijlstra F. Thrombus aspiration during primary percutaneous coronary intervention. N Engl J Med. 2008 Feb 7;358(6):557-67. doi: 10.1056/NEJMoa0706416. — View Citation

Thiele H, Schindler K, Friedenberger J, Eitel I, Fürnau G, Grebe E, Erbs S, Linke A, Möbius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16. — View Citation

Van de Werf F, Bax J, Betriu A, Blomstrom-Lundqvist C, Crea F, Falk V, Filippatos G, Fox K, Huber K, Kastrati A, Rosengren A, Steg PG, Tubaro M, Verheugt F, Weidinger F, Weis M; ESC Committee for Practice Guidelines (CPG). Management of acute myocardial infarction in patients presenting with persistent ST-segment elevation: the Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2008 Dec;29(23):2909-45. doi: 10.1093/eurheartj/ehn416. Epub 2008 Nov 12. — View Citation

Vetrovec GW. Improving reperfusion in patients with myocardial infarction. N Engl J Med. 2008 Feb 7;358(6):634-7. doi: 10.1056/NEJMe0708910. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size	Infarct size quantified by MR	Between 2 and 9 days after primary ptca	No
Secondary	Major Adverse Cardiac and Cerebrovascular Events (MACCE)	Cardiac mortality, reinfarction, new revascularization, and stroke	6 months	No