Back to resultsA Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function (Intracor)
Primary Purpose
Myocardial Infarction, Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Abciximab
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- St Vincent's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intracoronary abciximab (Reopro)
Control group
Arm Description
Intracoronary abciximab (Reopro)
Intracoronary Reopro
Outcomes
Primary Outcome Measures
Index of Microvascular Resistance
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
Incidence of periprocedural myocardial infarction
We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI
Full Information
NCT ID
NCT02105870
First Posted
December 9, 2013
Last Updated
April 2, 2014
Sponsor
University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT02105870
Brief Title
A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Acronym
Intracor
Official Title
A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intracoronary abciximab (Reopro)
Arm Type
Experimental
Arm Description
Intracoronary abciximab (Reopro)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Intracoronary Reopro
Intervention Type
Drug
Intervention Name(s)
Abciximab
Other Intervention Name(s)
Reopro
Intervention Description
This drug will be administered intracoronary before percutaneous coronary intervention.
Primary Outcome Measure Information:
Title
Index of Microvascular Resistance
Description
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.
Time Frame
within 3 hours
Secondary Outcome Measure Information:
Title
Incidence of periprocedural myocardial infarction
Description
We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI
Time Frame
within 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Wilson, MD PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3101
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
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