ANZCTR - Registration

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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

29/03/2021

Date data sharing statement initially provided

5/03/2019

Date results provided

29/03/2021

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]

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

Condition category

Condition code

Cardiovascular

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]

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]

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]

IMR is measured during the coronary angiogram (during index admission) before and immediately after percutaneous coronary intervention (if intervention is performed).

Secondary outcome [1]

- 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]

during repeat angiogram

Secondary outcome [2]

- 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]

during repeat angiogram

Secondary outcome [3]

- difference in left ventricular function between the 2 exposure groups assessing using transthoracic echocardiogram

Timepoint [3]

- 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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

Actual

23/02/2018

Date of last participant enrolment

Anticipated

Actual

11/07/2020

Date of last data collection

Anticipated

Actual

18/01/2021

Sample size

Target

128

Accrual to date

Final

128

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment hospital [2]

Campbelltown Hospital - Campbelltown

Recruitment postcode(s) [1]

2170 - Liverpool

Recruitment postcode(s) [2]

2560 - Campbelltown

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Abbott Australasia Pty Ltd

Address [1]

299 Lane Cove Road,
Macquarie Park NSW 2113

Country [1]

Australia

Primary sponsor type

Hospital

Name

Liverpool Hospital

Address

Elizabeth Street,
Liverpool NSW 2170

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Research and Ethics Office
Liverpool Hospital
Locked Bag 7103, LIVERPOOL BC, NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

21/08/2017

Approval date [1]

14/12/2017

Ethics approval number [1]

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

Dr James Xu

Address

Department of Cardiology,
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170

Country

Australia

Phone

+61 2 8738 3797

Fax

James.Xu@health.nsw.gov.au

Contact person for public queries

Name

James Xu

Address

Department of Cardiology,
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170

Country

Australia

Phone

+61 2 8738 3797

Fax

James.Xu@health.nsw.gov.au

Contact person for scientific queries

Name

James Xu

Address

Department of Cardiology,
Liverpool Hospital
Elizabeth Street, Liverpool NSW 2170

Country

Australia

Phone

+61 2 8738 3797

Fax

James.Xu@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Sensitive medical data

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Impact of Ticagrelor Versus Clopidogrel on Coronary Microvascular Function After Non-ST-Segment-Elevation Acute Coronary Syndrome.	2022	https://dx.doi.org/10.1161/CIRCINTERVENTIONS.121.011419
Embase	Early Effects of Ticagrelor Versus Clopidogrel on Peripheral Endothelial Function After Non-ST-Elevation Acute Coronary Syndrome and Assessment of Its Relationship With Coronary Microvascular Function.	2023	https://dx.doi.org/10.1016/j.amjcard.2023.06.009

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically