Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02105870
Registration number
NCT02105870
Ethics application status
Date submitted
9/12/2013
Date registered
7/04/2014
Date last updated
7/04/2014
Titles & IDs
Public title
A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Query!
Scientific title
A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Query!
Secondary ID [1]
0
0
SVH 001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Intracor
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction
0
0
Query!
Coronary Artery Disease
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Abciximab
Experimental: Intracoronary abciximab (Reopro) - Intracoronary abciximab (Reopro)
Placebo comparator: Control group - Intracoronary Reopro
Treatment: Drugs: Abciximab
This drug will be administered intracoronary before percutaneous coronary intervention.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Index of Microvascular Resistance
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
within 3 hours
Query!
Secondary outcome [1]
0
0
Incidence of periprocedural myocardial infarction
Query!
Assessment method [1]
0
0
We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI
Query!
Timepoint [1]
0
0
within 24 hours
Query!
Eligibility
Key inclusion criteria
* Patient with acute coronary syndromes
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
UNKNOWN
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/02/2012
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2014
Query!
Actual
Query!
Sample size
Target
40
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
St Vincent's Hospital - Fitzroy
Query!
Recruitment postcode(s) [1]
0
0
3101 - Fitzroy
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Melbourne
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02105870
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Andrew Wilson, MD PhD
Query!
Address
0
0
University of Melbourne
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02105870
Download to PDF