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Trial registered on ANZCTR


Registration number
ACTRN12618001610224
Ethics application status
Approved
Date submitted
20/09/2018
Date registered
27/09/2018
Date last updated
27/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing and improving coronary microvascular (small artery) function in non-ST elevation acute coronary syndromes (heart attacks)
Scientific title
Comparing effects of clopidogrel versus ticagrelor anti-platelet therapy on coronary microvascular function after non-ST elevation acute coronary syndromes (NSTE-ACS): a prospective randomised study
Secondary ID [1] 295854 0
None
Universal Trial Number (UTN)
Trial acronym
ANTMAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-ST elevation acute coronary syndrome 309314 0
Condition category
Condition code
Cardiovascular 308182 308182 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients hospitalised for non-ST elevation acute coronary syndrome (a type of heart attack) and scheduled for coronary angiogram +/- percutaneous coronary intervention (procedure to open narrowed arteries) are eligible to participate. On admission, participants will be randomised to receive either clopidogrel (intervention) 300mg loading then 75mg daily, given orally, or ticagrelor (comparator) 180mg loading then 90mg twice-daily, given orally. Both are approved blood-thinning medications for heart attacks. The duration of these medications will be up to the discretion of the treating Cardiologist, and may range from 1 day up to 1 year or longer. During the angiogram procedure (which will occur no later than 72 hrs after admission), all patients will have their index of microcirculatory resistance (IMR) measured using a standard pressure wire. In patients requiring a clinically indicated repeat coronary angiogram, the IMR measurement will be also repeated at that time.
Intervention code [1] 312320 0
Treatment: Drugs
Comparator / control treatment
This trial is a non-blinded, open-label, prospective randomised study. Participants will be randomised to receive either clopidogrel (300mg loading then 75mg daily) or ticagrelor (180mg loading then 90mg twice-daily) on admission (both are blood-thinners approved for the treatment of heart attacks). Treatment is otherwise at the discretion of the treating clinician.
Control group
Active

Outcomes
Primary outcome [1] 307326 0
Difference in coronary microvascular function between the 2 exposure groups as measured by index of microcirculatory resistance (IMR). The IMR is measured in the Cardiac catheter laboratory during invasive coronary angiogram, using standard pressure-temperature sensor intra-coronary guidewires.
Timepoint [1] 307326 0
IMR is measured during the coronary angiogram (during index admission) before and immediately after percutaneous coronary intervention (if intervention is performed).
Secondary outcome [1] 351487 0
- In patients undergoing clinically indicated repeat coronary angiograms: difference in IMR between the 2 exposure groups during follow-up angiogram, assessed using standard intra-coronary pressure-temperature sensor intra-coronary guidewires
Timepoint [1] 351487 0
during repeat angiogram
Secondary outcome [2] 352334 0
- In patients undergoing clinically indicated repeat coronary angiograms: difference in coronary flow reserve (CFR) between the 2 exposure groups during follow-up angiogram, assessed using standard intra-coronary pressure-temperature sensor intra-coronary guidewires
Timepoint [2] 352334 0
during repeat angiogram
Secondary outcome [3] 352335 0
- difference in left ventricular function between the 2 exposure groups assessing using transthoracic echocardiogram
Timepoint [3] 352335 0
- at 6 months

Eligibility
Key inclusion criteria
Patients hospitalised for non-ST elevation acute coronary syndrome and scheduled for coronary angiogram +/- percutaneous coronary intervention
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous coronary bypass grafting
2. Prior myocardial infarction in target territory
3. Renal dysfunction with eGFR <30 mL/min/1.73m^2
4. Need for chronic oral anticoagulant therapy
5. Cardiogenic shock
6. Contraindications to adenosine
7. Pregnancy
8. Inability to give informed consent

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11802 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 11803 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 23929 0
2170 - Liverpool
Recruitment postcode(s) [2] 23930 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 300454 0
Self funded/Unfunded
Name [1] 300454 0
Address [1] 300454 0

Country [1] 300454 0
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth Street,
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 299918 0
None
Name [1] 299918 0
Address [1] 299918 0
Country [1] 299918 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301257 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 301257 0
Research and Ethics Office
Liverpool Hospital
Locked Bag 7103, LIVERPOOL BC, NSW 1871
Ethics committee country [1] 301257 0
Australia
Date submitted for ethics approval [1] 301257 0
21/08/2017
Approval date [1] 301257 0
14/12/2017
Ethics approval number [1] 301257 0
Local project number HE17/195

Summary
Brief summary
Current treatment of heart attacks focuses on the large arteries of the heart where the blockages can be seen with injection of X­ray dye (contrast). However, the small arteries of the heart are increasingly recognised to play a key role in affecting the outcome of patients after heart attacks. The function of the small arteries of the heart may be worsened by heart attacks and by balloons and stenting procedures to unblock the main arteries. It can also be worsened by life style factors like smoking and high cholesterol. The index of microcirculatory resistance (IMR) is a new measure and has been shown to be a highly precise and reliable method of assessing the function of the small arteries of the heart. However, it is unclear if this new measure applies to patients after non-ST elevation acute coronary syndromes (NSTE-ACS), which is the most common form of heart attacks presenting to hospitals. This study aims to use IMR to examine ways to improve function of the small arteries of the heart in patients after NSTE-­ACS. We plan to primarily examine the effects of 2 different blood thinners (anti-platelet agents), clopidogrel and ticagrelor, on the IMR after NSTE-ACS. Both drugs are approved treatments for NSTE­-ACS. All participants will receive standard medical care as determined by their treating doctors.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86386 0
Dr James Xu
Address 86386 0
Department of Cardiology,
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170
Country 86386 0
Australia
Phone 86386 0
+61 2 8738 3797
Fax 86386 0
Email 86386 0
James.Xu@health.nsw.gov.au
Contact person for public queries
Name 86387 0
Dr James Xu
Address 86387 0
Department of Cardiology,
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170
Country 86387 0
Australia
Phone 86387 0
+61 2 8738 3797
Fax 86387 0
Email 86387 0
James.Xu@health.nsw.gov.au
Contact person for scientific queries
Name 86388 0
Dr James Xu
Address 86388 0
Department of Cardiology,
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170
Country 86388 0
Australia
Phone 86388 0
+61 2 8738 3797
Fax 86388 0
Email 86388 0
James.Xu@health.nsw.gov.au

No data has been provided for results reporting
Summary results
Not applicable