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

February 20, 2012 updated by: J.Moreu, Hospital Virgen de la Salud

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Toledo, Spain, 45004
        • Recruiting
        • Hospital Virgen de la Salud
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Abciximab, thrombus aspiration catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size
Time Frame: Between 2 and 9 days after primary ptca
Infarct size quantified by MR
Between 2 and 9 days after primary ptca

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: 6 months
Cardiac mortality, reinfarction, new revascularization, and stroke
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Virgen de la Salud

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 27, 2011

First Posted (Estimate)

June 28, 2011

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-2008/52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Intracoronary direct injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe