Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function
Secondary ID [1] 0 0
SVH 001
Universal Trial Number (UTN)
Trial acronym
Intracor
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Index of Microvascular Resistance
Timepoint [1] 0 0
within 3 hours
Secondary outcome [1] 0 0
Incidence of periprocedural myocardial infarction
Timepoint [1] 0 0
within 24 hours

Eligibility
Key inclusion criteria
- Patient with acute coronary syndromes
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient with untreated malignancy, disseminated malignancy, active inflammatory
diseases, active infectious diseases patients unable to give informed consent Patients
with STEMI

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2014
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
3101 - Fitzroy

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02105870
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Wilson, MD PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02105870