Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen

Sponsor
Azienda Sanitaria Ospedaliera (Other)
Overall Status
Terminated
CT.gov ID
NCT00320229
Collaborator
Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy (Other)
84
1
7
12.1

Study Details

Study Description

Brief Summary

The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. Intracoronary use of abciximab has reported favourable results. We randomly assigned 84 patients to intracoronary half abciximab bolus (group A) and to standard regimen (group B).

Study Design

Study Type:
Interventional
Study Start Date :
Dec 1, 2004
Study Completion Date :
Jul 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • presenting with unstable angina

    • presenting with acute myocardial infarction

    • eligibility for percutaneous coronary intervention

    Exclusion Criteria:
    • presenting with cardiogenic shock

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiologia 2 - Emodinamica - Ospedale Maggiore Novara Italy 28100

    Sponsors and Collaborators

    • Azienda Sanitaria Ospedaliera
    • Cardiologia 2 - Emodinamica - Ospedale Maggiore, Novara, Italy

    Investigators

    • Principal Investigator: Mara Sansa, Chief Interventional Cardiology - Ospedale Maggiore - Novara - Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00320229
    Other Study ID Numbers:
    • ABCX-LD
    First Posted:
    May 3, 2006
    Last Update Posted:
    May 16, 2006
    Last Verified:
    Jan 1, 2006

    Study Results

    No Results Posted as of May 16, 2006