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

Primary Purpose

Myocardial Infarction, Occlusive Thrombus

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Intracoronary direct injection

Intracoronary and distal injection by aspiration device

Intracoronary distal injection by aspiration catheter device

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Primary PTCA, Thrombus Aspiration Catheter, Intracoronary Abciximab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Virgen de la SaludRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

GROUP A

GROUP B

GROUP C

Arm Description

Intracoronary full bolus dose of abciximab proximal to thrombus occlusion

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

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

Outcomes

Primary Outcome Measures

Infarct size

Infarct size quantified by MR

Secondary Outcome Measures

Major Adverse Cardiac and Cerebrovascular Events (MACCE)

Cardiac mortality, reinfarction, new revascularization, and stroke

Full Information

NCT ID

NCT01383785

First Posted

June 22, 2011

Last Updated

February 20, 2012

Sponsor

Hospital Virgen de la Salud

1. Study Identification

Unique Protocol Identification Number

NCT01383785

Brief Title

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

Acronym

TOLEDO1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2009 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Virgen de la Salud

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Occlusive Thrombus

Keywords

Primary PTCA, Thrombus Aspiration Catheter, Intracoronary Abciximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GROUP A

Arm Type

Active Comparator

Arm Description

Intracoronary full bolus dose of abciximab proximal to thrombus occlusion

Arm Title

GROUP B

Arm Type

Experimental

Arm Description

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

Arm Title

GROUP C

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Intracoronary direct injection

Other Intervention Name(s)

Abciximab, thrombus aspiration catheter

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Intracoronary and distal injection by aspiration device

Other Intervention Name(s)

Abciximab, thrombus aspiration catheter

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Intracoronary distal injection by aspiration catheter device

Other Intervention Name(s)

Abciximab, thrombus aspiration catheter

Intervention Description

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.

Primary Outcome Measure Information:

Title

Infarct size

Description

Infarct size quantified by MR

Time Frame

Between 2 and 9 days after primary ptca

Secondary Outcome Measure Information:

Title

Major Adverse Cardiac and Cerebrovascular Events (MACCE)

Description

Cardiac mortality, reinfarction, new revascularization, and stroke

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jose Moreu, MD,PhD

Phone

+34 925 269 188

jmoreu@sescam.jccm.es

First Name & Middle Initial & Last Name or Official Title & Degree

Fernando Pajin, MD

Phone

+34 925 269 188

lfpajinv@sescam.jccm.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Moreu, Phd,MD

Organizational Affiliation

Hospital Virgen de la Salud. Toledo. Spain

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luis Rodriguez-Padial, Phd MD

Organizational Affiliation

Hospital Virgen de la Salud

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Virgen de la Salud

City

Toledo

ZIP/Postal Code

45004

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose Moreu, pHD,md

Phone

+34 925 269 188

jmoreu@sescam.jccm.es

First Name & Middle Initial & Last Name & Degree

Tomas Canton, MD

First Name & Middle Initial & Last Name & Degree

Fernando Pajin, MD

First Name & Middle Initial & Last Name & Degree

Esther Lazaro, MD

First Name & Middle Initial & Last Name & Degree

Daniel Nuñez, MD

First Name & Middle Initial & Last Name & Degree

Belen Santos, MD

First Name & Middle Initial & Last Name & Degree

Ana Garcia de Castro, MD

First Name & Middle Initial & Last Name & Degree

Ramon Barciela, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19004841

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.

Results Reference

background

PubMed Identifier

18256391

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.

Results Reference

background

PubMed Identifier

18256399

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.

Results Reference

background

PubMed Identifier

18559698

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.

Results Reference

background

PubMed Identifier

18617066

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.

Results Reference

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

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