A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Intracor
A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedApril 7, 2014
April 1, 2014
2.3 years
December 9, 2013
April 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
within 3 hours
Secondary Outcomes (1)
Incidence of periprocedural myocardial infarction
within 24 hours
Study Arms (2)
Intracoronary abciximab (Reopro)
EXPERIMENTALIntracoronary abciximab (Reopro)
Control group
PLACEBO COMPARATORIntracoronary Reopro
Interventions
This drug will be administered intracoronary before percutaneous coronary intervention.
Eligibility Criteria
You may qualify if:
- Patient with acute coronary syndromes
You may not qualify if:
- Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Vincent's Hospital
Fitzroy, Victoria, 3101, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Wilson, MD PhD
University of Melbourne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 9, 2013
First Posted
April 7, 2014
Study Start
February 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
April 7, 2014
Record last verified: 2014-04