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Trial registered on ANZCTR


Registration number
ACTRN12619000423112
Ethics application status
Approved
Date submitted
10/03/2019
Date registered
14/03/2019
Date last updated
15/03/2019
Date data sharing statement initially provided
14/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The STAR-PAD trial is testing a new treatment for Peripheral Arterial Disease (PAD).
Scientific title
STimulating ß3 Adrenergic Receptors to improve change in exercise performance on a graded treadmill in patients with Peripheral Arterial Disease.
Secondary ID [1] 297677 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
STAR-PAD (STimulating ß3 Adrenergic Receptors to improve clinical outcomes in patients with Peripheral Arterial Disease)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 311956 0
Condition category
Condition code
Cardiovascular 310532 310532 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) Initial therapy with Mirabegron (50 mg/day) for 12 weeks.
-Mirabegron (produced by Astellas Pharmaceuticals) is a film-coated prolonged release oral tablet and it will be administered at a dose of 50 mg/day.
OR
(2) Placebo

Strategies used to monitor adherence to the intervention:
-At 4 weeks and 12 weeks participants will be self-reporting medication adherence (patient diary).
-Participants will be instructed to return unused capsules at 12 weeks and returned capsules will be counted by the study team and returned to Pharmacy department at RNSH
-Blood tests through the whole study (Screening, baseline, Week 4, Week 12).

Intervention code [1] 313909 0
Treatment: Drugs
Comparator / control treatment
Control treatment will be those participants in the placebo group.
Placebo-Placebo capsule formulation is gelatin packed with microcrystalline cellulose.
Control group
Placebo

Outcomes
Primary outcome [1] 319401 0
Change in exercise performance on a graded treadmill, reflecting the peak exercise capacity of the patient, as reflected by peak walking time.
Timepoint [1] 319401 0
Peak walking time at t=12 week vs screening and baseline, according to the Skinner-Gardner protocol.
Secondary outcome [1] 368026 0
Initial claudication distance as assessed by graded treadmill
Timepoint [1] 368026 0
Data will be compared between baseline and 12 weeks visit (end of treatment)
Secondary outcome [2] 368027 0
Walking Impairment Questionnaire
Timepoint [2] 368027 0
At baseline visit and 12 Weeks(end of treatment) follow up visit.
Secondary outcome [3] 368028 0
Ankle brachial index (ABI)-A validated and clinically utilized tool, will be measured after 10 minutes of supine rest with a hand-held Doppler.
Timepoint [3] 368028 0
At screening visit and 12 weeks (end of treatment( follow up visit
Secondary outcome [4] 368029 0
MRI measurements of flow-arterial blood of the lower limb coil
Timepoint [4] 368029 0
At baseline visit and 12 weeks (end of treatment) follow up visit
Secondary outcome [5] 368147 0
MRI measures of tissue perfusion
Timepoint [5] 368147 0
At baseline and 12 weeks (end of treatment) follow up visit
Secondary outcome [6] 368148 0
MRI measure of arterial stiffness
Timepoint [6] 368148 0
At baseline and 12 weeks (end of treatment) follow up visit
Secondary outcome [7] 368150 0
Quality of life questionnaire-SF36
Timepoint [7] 368150 0
At baseline visit and 12 weeks (end of treatment) follow up study
Secondary outcome [8] 368157 0
Initial absolute claudication distance as assessed by graded treadmill.
Timepoint [8] 368157 0
Data will be compared between baseline and 12 weeks (end of treatment) follow up.

Eligibility
Key inclusion criteria
1) Age 40-80 yrs;
2) Atherosclerotic PAD (uni- or bi-lateral) with a resting ankle-brachial index (ABI) <0.90;
3) Stable intermittent claudication for the previous 3 months not requiring revascularization;
4) Ability to walk 1 to 12 minutes on a treadmill with a variability of PWT between 2 consecutive screening treadmill tests <25%;
5) Adherence to a stable medical regimen for 3 months
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Ischaemic rest pain, ulceration or gangrene, or previous major amputation;
2) Acute coronary syndrome or revascularization of coronary/peripheral arteries in last 3 months;
3) Uncontrolled hypertension (>180/100 mm Hg);
4) Active inflammatory, infectious, or autoimmune diseases;
5) Significant renal impairment (eGFR<45);
6) Concomitant illness, physical impairment or mental condition that could interfere with effective conduct of the study during its duration, including life expectancy <3 months.
7) Contraindication to mirabegron

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
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] 13352 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 13353 0
Westmead Hospital - Westmead
Recruitment hospital [3] 13354 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 25953 0
2050 - Camperdown
Recruitment postcode(s) [2] 25951 0
2065 - St Leonards
Recruitment postcode(s) [3] 25952 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 302204 0
Charities/Societies/Foundations
Name [1] 302204 0
Heart Foundation
Address [1] 302204 0
Level 3, 80 William Street, East Sydney, NSW 2011
Country [1] 302204 0
Australia
Primary sponsor type
Government body
Name
North Sydney Local Health District
Address
Reserve Rd, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 302047 0
None
Name [1] 302047 0
Address [1] 302047 0
Country [1] 302047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302883 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 302883 0
Level 13, Research Office, Kolling Building, Royal North Shore Hospital, Pacific Highway, St Leonards NSW 2065
Ethics committee country [1] 302883 0
Australia
Date submitted for ethics approval [1] 302883 0
29/01/2018
Approval date [1] 302883 0
17/04/2018
Ethics approval number [1] 302883 0
HREC/18/HAWKE/50

Summary
Brief summary
STAR-PAD trial intend to answer the question of: Does the ß3AR agonist Mirabegron (50 mg/day), administered for 12 weeks, improve lower limb perfusion and intermittent claudication in patients with PAD compared with placebo control? The intervention will be oral tablet Mirabegron 50mg/day for 12 weeks vs Placebo, The primary outcome will be improvement in peak walk time (PWT) on a graded treadmill test

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91726 0
Prof Gemma Figtree
Address 91726 0
Reserve Rd, Kolling Institute, Level 12, Kolling building | Royal North Shore Hospital | NSW | 2065
Country 91726 0
Australia
Phone 91726 0
+61 2 9926 4915
Fax 91726 0
Email 91726 0
gemma.figtree@sydney.edu.au
Contact person for public queries
Name 91727 0
Ms Yin Wang
Address 91727 0
Reserve Rd, Kolling Institute, Level 12, Kolling building | Royal North Shore Hospital | NSW | 2065
Country 91727 0
Australia
Phone 91727 0
+61 2 99264792
Fax 91727 0
Email 91727 0
Yin.Wang@sydney.edu.au
Contact person for scientific queries
Name 91728 0
Dr Kristen Bubb
Address 91728 0
Reserve Rd, Level 12, Kolling Building, Royal North Shore Hospital | St Leonards | NSW | 2065
Country 91728 0
Australia
Phone 91728 0
+61 2 9926 4916
Fax 91728 0
Email 91728 0
kristen.bubb@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
At the completion of the study, all data will be analysed in a blinded manner and reports with conclusions will be generated. Patients will be allowed access to the summary results at their request.
When will data be available (start and end dates)?
Individual participant data will be collected after they signing the consent, and all data will be up-loaded to Redcap database. After anyalysis of this data and the end of patient follow-up all data shall be stored in accordance with research guidelines and destroyed after 15 years in accordance with the Australian code for the responsible conduct of Research.
Available to whom?
-Patients will be allowed access to the summary results at their request.
-Researchers
-Any event that meets the definition of a SUSAR will be reported to the local HREC and the -relevant regulatory authorities as per local requirements and ICH Clinical Safety Data Management.
Available for what types of analyses?
Analysis of covariance (ANCOVA)-Primary and Continuous secondary outcomes.
Kruskal-Wallis analysis of variance and Wilcoxon rank sum tests-QOL measures and brachial artery flow-mediated dilation.
Log-binomial regression-binary endpoints
Pre-defined subgroup analyses
How or where can data be obtained?
Data access authorization-PI
What supporting documents are/will be available?
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1563 0
Informed consent form
Citation [1] 1563 0
Link [1] 1563 0
Email [1] 1563 0
Other [1] 1563 0
PISCF-STAR PAD Trial-most up to date version
Type [2] 1564 0
Ethical approval
Citation [2] 1564 0
Link [2] 1564 0
Email [2] 1564 0
Other [2] 1564 0
Initial Approval
Type [3] 1565 0
Ethical approval
Citation [3] 1565 0
Link [3] 1565 0
Email [3] 1565 0
Other [3] 1565 0
Most up to date approval
Summary results
No Results