Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01383785
Recruitment Status : Unknown
Verified February 2012 by J.Moreu, Hospital Virgen de la Salud.
Recruitment status was:  Recruiting
First Posted : June 28, 2011
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
J.Moreu, 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Occlusive Thrombus Other: Intracoronary direct injection Other: Intracoronary and distal injection by aspiration device Other: Intracoronary distal injection by aspiration catheter device Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Primary Angioplasty Combined Distal Injection of Abciximab to Thrombus and Aspiration With Catheter
Study Start Date : November 2009
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
Drug Information available for: Abciximab

Arm Intervention/treatment
Active Comparator: GROUP A
Intracoronary full bolus dose of abciximab proximal to thrombus occlusion
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.

Other Name: Abciximab, thrombus aspiration catheter

Experimental: GROUP B
Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter
Other: 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.

Other Name: Abciximab, thrombus aspiration catheter

Experimental: GROUP C
Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter
Other: 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.

Other Name: Abciximab, thrombus aspiration catheter




Primary Outcome Measures :
  1. Infarct size [ Time Frame: Between 2 and 9 days after primary ptca ]
    Infarct size quantified by MR


Secondary Outcome Measures :
  1. Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 6 months ]
    Cardiac mortality, reinfarction, new revascularization, and stroke



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01383785


Contacts
Layout table for location contacts
Contact: Jose Moreu, MD,PhD +34 925 269 188 jmoreu@sescam.jccm.es
Contact: Fernando Pajin, MD +34 925 269 188 lfpajinv@sescam.jccm.es

Locations
Layout table for location information
Spain
Hospital Virgen de la Salud Recruiting
Toledo, Spain, 45004
Contact: Jose Moreu, pHD,md    +34 925 269 188    jmoreu@sescam.jccm.es   
Principal Investigator: Tomas Canton, MD         
Principal Investigator: Fernando Pajin, MD         
Principal Investigator: Esther Lazaro, MD         
Principal Investigator: Daniel Nuñez, MD         
Principal Investigator: Belen Santos, MD         
Principal Investigator: Ana Garcia de Castro, MD         
Principal Investigator: Ramon Barciela, MD         
Sponsors and Collaborators
Hospital Virgen de la Salud
Investigators
Layout table for investigator information
Principal Investigator: Jose Moreu, Phd,MD Hospital Virgen de la Salud. Toledo. Spain
Study Director: Luis Rodriguez-Padial, Phd MD Hospital Virgen de la Salud
Publications:

Layout table for additonal information
Responsible Party: J.Moreu, Director catheterization laboratory, Hospital Virgen de la Salud
ClinicalTrials.gov Identifier: NCT01383785    
Other Study ID Numbers: PI-2008/52
First Posted: June 28, 2011    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012
Keywords provided by J.Moreu, Hospital Virgen de la Salud:
Primary PTCA
Thrombus Aspiration Catheter
Intracoronary Abciximab
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Thrombosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Abciximab
Anticoagulants
Platelet Aggregation Inhibitors