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A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function (Intracor)

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ClinicalTrials.gov Identifier: NCT02105870
Recruitment Status : Unknown
Verified April 2014 by A/P Andrew Wilson, University of Melbourne.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2014
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
A/P Andrew Wilson, University of Melbourne

Study Description
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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
Myocardial Infarction Coronary Artery Disease Drug: Abciximab Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Abciximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intracoronary abciximab (Reopro)
Intracoronary abciximab (Reopro)
 Drug: Abciximab
This drug will be administered intracoronary before percutaneous coronary intervention.
Other Name: Reopro
Placebo Comparator: Control group
Intracoronary Reopro


Outcome Measures
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Primary Outcome Measures :
  1. Index of Microvascular Resistance [ Time Frame: 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 [ Time Frame: within 24 hours ]
    We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT02105870


Locations
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Australia, Victoria
St Vincent's Hospital
Fitzroy, Victoria, Australia, 3101
Sponsors and Collaborators
University of Melbourne
Investigators
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Principal Investigator: Andrew Wilson, MD PhD University of Melbourne
More Information
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Responsible Party: A/P Andrew Wilson, Associate Professor, University of Melbourne
ClinicalTrials.gov Identifier: NCT02105870    
Other Study ID Numbers: SVH 001
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Abciximab
Anticoagulants
Platelet Aggregation Inhibitors