The STAR-PAD trial is testing a new treatment for Peripheral Arterial Disease (PAD).

Conditions

None listed

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

Kristen J. Bubb, Jason A. Harmer, Meghan Finemore, Sarah Aitken, Zara Ali et al. (16 authors)

BMJ Open2021-09-017 citations

10.1136/bmjopen-2021-049858

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

(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).

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Healthy volunteers

No

Inclusion criteria

1) Age above 40. 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 more than 1 minute 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

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

Outcome results