Clinical trial NCT01383785: Thrombus Aspiration for OcLuded Coronary Artery Enhanced With Distal Injection Of Abciximab
Official title: Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Occlusive Thrombus
Keywords: Primary PTCA
Thrombus Aspiration Catheter
Intracoronary Abciximab
Lead sponsor: Hospital Virgen de la Salud
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Infarct size
timeFrame: Between 2 and 9 days after primary ptca
Secondary outcomes:
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 6 months
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
Study officials:
affiliation: Hospital Virgen de la Salud. Toledo. Spain
name: Jose Moreu, Phd,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Salud
name: Luis Rodriguez-Padial, Phd MD
role: STUDY_DIRECTOR
References:
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. No abstract available.
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.
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. No abstract available.
citation: Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-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.
citation: 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.