Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001174471
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
13/10/2025
Date registered
Help: Date registered
28/10/2025
Date last updated
Help: Date last updated
28/10/2025
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
COMparative Pharmacotherapy And peRsonalised stratEgy in the management of Coronary Microvascular Dysfunction double blind randomised controlled Trial - Part II
Scientific title
COMparative Pharmacotherapy And peRsonalised stratEgy in the management of Coronary Microvascular Dysfunction double blind randomised controlled Trial - Part II
Additional trial identifiers [1] 315563 0
None
Universal Trial Number (UTN)
Trial acronym
COMPARE CMD - II
Related trial records

Health condition
Health condition(s) studied:
Coronary microvascular dysfunction 339195 0
Angina with non obstructive coronary artery disease 339196 0
Condition category
Condition code
Cardiovascular 335470 335470 0 0
Coronary heart disease
Cardiovascular 335471 335471 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This is a two-part interventional clinical trial investigating the treatment of patients with angina and no obstructive coronary artery disease (ANOCA), specifically in patients with coronary microvascular dysfunction.

Patients completing Part I will be enrolled into Part II of the trial.

Study II is a randomised controlled phase where participants are allocated to one of two arms:
• Physician-directed care (standard current practice)
• Personalised therapy, based on their individualised drug response profile from Study I

Participants will undergo a stress echocardiogram and complete the Seattle Angina Questionnaire at the beginning and end of the 8-week follow-up period.

In the personalised therapy arm, the referring cardiologist of the patient will be given the results of Part 1 of the clinical trial (i.e Top three drugs that improve the participants IMR and CFR) and be encouraged to commence the patient on these drugs. Referring cardiologists in the Physician directed arm will not be given the results of Part 1 and will be advised to commence the patient on guideline directed therapy (as per CSANZ, ESC and ACC guidelines for ANOCA).

All participants will be under the care of the primary/referring cardiologist with decision of medication changes/commencement will be left to them. The participants in both the group will be followed up months either via face to face visits or over the phone to assess and encourage adherence to the medications commenced by their cardiologists.
Intervention code [1] 332189 0
Treatment: Other
Intervention code [2] 332239 0
Treatment: Drugs
Description of the comparator or control
Study II comparator: Physician directed care for coronary microvascular dysfunction.

Referring cardiologists in the Physician directed arm will not be given the results of Part 1 and will be advised to commence the patient on guideline directed therapy (as per CSANZ, ESC and ACC guidelines for ANOCA). All participants will be under the care of the primary/referring cardiologist with decision of medication changes/commencement will be left to them. The participants in both the group will be followed up months either via face to face visits or over the phone to assess and encourage adherence to the medications commenced by their cardiologists.
Control group
Active

Outcomes
Primary outcome [1] 343029 0
Study II: Change in angina symptoms as measured by the SAQs questionnaires between arms.
Timepoint [1] 343029 0
Measured at baseline and at 8 weeks (end of trial) between arms
Secondary outcome [1] 453193 0
Study II Change in endothelial function markers between treatment arms Baseline and 8 weeks (end of treatment)
Timepoint [1] 453193 0
Baseline and 8 weeks (end of treatment)
Secondary outcome [2] 453194 0
Exercise capacity as measured by exercise time and metabolic equivalent of task (METS)
Timepoint [2] 453194 0
Baseline and 8 (end of treatment)
Secondary outcome [3] 453195 0
Change in quality of life between arms
Timepoint [3] 453195 0
Baseline and 8 weeks (end of treatment)

Eligibility
Key inclusion criteria
INCLUSION CRITERIA

1. Adult men and women aged 18 years and over
2. Patients referred for coronary angiography with ischemic symptoms such as chest pain or angina equivalent.
3. Coronary angiography diagnosis of non-obstructive coronary arteries (Fractional flow reserve {FFR] >0.8)
4. Index of Microcirculation >25
5. Negative pregnancy test (fertile women). Fertile women must use safe contraceptives (spiral, hormonal contraceptives) for the duration of the study
6. Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances
7. Able to personally read and understand the Participant Information and Consent Form and provide written, signed and data informed consent to participate in the study (health care interpreters will be engaged for people with cultural and linguistically diverse backgrounds).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
EXCLUSION CRITERIA

1. Cardiogenic shock
2. Coronary angiography revealing obstructive coronary arteries in major epicardial arteries (FFR< 0.8)
3. Non-coronary indication for invasive angiography (e.g. valvular heart disease and cardiomyopathy)
4. Myocardial infarction within 90 days
5. Advanced Kidney Disease (eGFR <30mL/minute per 1.73m2)
6. Severe liver insufficiency (Child-Pugh class C)
7. Severe obstructive airways – any prior admission to ICU or general hospital admission in the past 12 months for infective exacerbation of airways disease.
8. Active internal bleeding or history of haemorrhagic diathesis (including heparin-induced thrombocytopenia)
9. Recent use of vasospastic agents, such as cocaine, triptans, or ergot alkaloids (in the last 1 month)
10. Major Surgery (e.g., CABG) or trauma within the previous 6 weeks
11. Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration (this is routine practice prior to coronary angiography).
12. Inability to provide informed consent (compromised mental status e.g., dementia, too ill) for clinically indicated coronary angiography
13. Currently a prisoner (has been admitted to hospital via a correctional facility)
14. Contraindications to drugs and devices (Adenosine, GTN, Acetylcholine or medications in the Compare-CMD trial)
15. Heavily calcified or tortuous vessels leading to inability to advance pressure wire

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)
Central Randomisation process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 28641 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 28642 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 44870 0
2139 - Concord
Recruitment postcode(s) [2] 44871 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 320168 0
Government body
Name [1] 320168 0
Sydney Local Health District
Country [1] 320168 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 322724 0
None
Name [1] 322724 0
Address [1] 322724 0
Country [1] 322724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318705 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 318705 0
Ethics committee country [1] 318705 0
Australia
Date submitted for ethics approval [1] 318705 0
28/07/2025
Approval date [1] 318705 0
29/09/2025
Ethics approval number [1] 318705 0
Ethics committee name [2] 318707 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [2] 318707 0
Ethics committee country [2] 318707 0
Australia
Date submitted for ethics approval [2] 318707 0
28/07/2025
Approval date [2] 318707 0
Ethics approval number [2] 318707 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 145006 0
Prof Andy Yong
Address 145006 0
Concord General Repatriation Hospital, Hospital Road, Concord, NSW 2139
Country 145006 0
Australia
Phone 145006 0
+61 297678390
Fax 145006 0
Email 145006 0
[email protected]
Contact person for public queries
Name 145007 0
Dr Jayant Ravindran
Address 145007 0
Concord General Repatriation Hospital, Hospital Road, Concord, NSW 2139
Country 145007 0
Australia
Phone 145007 0
+61 297678390
Fax 145007 0
Email 145007 0
[email protected]
Contact person for scientific queries
Name 145008 0
Dr Jayant Ravindran
Address 145008 0
Concord General Repatriation Hospital, Hospital Road, Concord, NSW 2139
Country 145008 0
Australia
Phone 145008 0
+61 297678390
Fax 145008 0
Email 145008 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.