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A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function

Sponsor
University of Melbourne (Other)
Overall Status
Unknown status
CT.gov ID
NCT02105870
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
28
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients suffering an acute myocardial infarction.

The investigators hypothesise that treatment with intracoronary abciximab, a potent anti platelet agent, at the time of coronary stent insertion, will improve microvascular function.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

The index of microcirculatory resistance (IMR), an invasive measure of coronary microvascular function, correlates with clinical outcomes in patients with stable angina and ST elevation myocardial infarction. The glycoprotein IIb/IIIa receptor inhibitor, abciximab, improves coronary microvascular function and reduces major cardiac adverse events in patients with acute coronary syndromes. This study will investigate whether an intracoronary bolus of abciximab in patients with non-ST elevation myocardial infarction decreases IMR and improves microvascular function.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Study Start Date :
Feb 1, 2012
Anticipated Primary Completion Date :
Jun 1, 2014
Anticipated Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intracoronary abciximab (Reopro)

Intracoronary abciximab (Reopro)

Drug: Abciximab
This drug will be administered intracoronary before percutaneous coronary intervention.
Other Names:
  • Reopro

    		•
    Placebo Comparator: Control group

    Intracoronary Reopro

    Outcome Measures

    Primary Outcome Measures

    1. Index of Microvascular Resistance [within 3 hours]

      We will assess IMR in the catheterisation laboratory immediately before PCI, then intracoronary reopro or placebo will be administered and we will re-assess IMR 15 minutes post delivery of the study drug. Finally we will perform PCI and immediately measure IMR post-procedure.

    Secondary Outcome Measures

    1. Incidence of periprocedural myocardial infarction [within 24 hours]

      We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with acute coronary syndromes
    Exclusion Criteria:
    • Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Vincent's Hospital Fitzroy Victoria Australia 3101

    Sponsors and Collaborators

    • University of Melbourne

    Investigators

    • Principal Investigator: Andrew Wilson, MD PhD, University of Melbourne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    A/P Andrew Wilson, Associate Professor, University of Melbourne
    ClinicalTrials.gov Identifier:
    NCT02105870
    Other Study ID Numbers:
    • SVH 001
    First Posted:
    Apr 7, 2014
    Last Update Posted:
    Apr 7, 2014
    Last Verified:
    Apr 1, 2014
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Infarction
    Infarction
    Abciximab

    Study Results

    No Results Posted as of Apr 7, 2014