The STAR-PAD trial is testing a new treatment for Peripheral Arterial Disease (PAD).
STimulating ß3 Adrenergic Receptors to improve change in exercise performance on a graded treadmill in patients with Peripheral Arterial Disease.
North Sydney Local Health District
100 participants
Mar 14, 2019
Interventional
Conditions
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
Eligibility
Inclusion Criteria5
- Age above 40.
- Atherosclerotic PAD (uni- or bi-lateral) with a resting ankle-brachial index (ABI) <0.90;
- Stable intermittent claudication for the previous 3 months not requiring revascularization;
- Ability to walk more than 1 minute on a treadmill with a variability of PWT between 2 consecutive screening treadmill tests <25%;
- Adherence to a stable medical regimen for 3 months
Exclusion Criteria7
- Ischaemic rest pain, ulceration or gangrene, or previous major amputation;
- Acute coronary syndrome or revascularization of coronary/peripheral arteries in last 3 months;
- Uncontrolled hypertension (>180/100 mm Hg);
- Active inflammatory, infectious, or autoimmune diseases;
- Significant renal impairment (eGFR<45);
- Concomitant illness, physical impairment or mental condition that could interfere with effective conduct of the study during its duration, including life expectancy <3 months.
- Contraindication to mirabegron
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Interventions
(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).
Locations(3)
View Full Details on ANZCTR
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ACTRN12619000423112