mirabegron and Peripheral-Arterial-Disease

There is currently only one approved medication effective at improving walking distance in people with intermittent claudication. Preclinical data suggest that the β. The STAR-PAD trial is a Phase II, multicentre, double-blind, randomised, placebo-controlled trial of mirabegron versus placebo on walking distance in patients with PAD. A total of 120 patients aged ≥40 years with stable PAD and intermittent claudication will be randomly assigned (1:1 ratio) to receive either mirabegron (50 mg orally once a day) or matched placebo, for 12 weeks. The primary endpoint is change in peak walking distance as assessed by a graded treadmill test. Secondary endpoints will include: (i) initial claudication distance; (ii) average daily step count and total step count and (iii) functional status and quality of life assessment. Mechanistic substudies will examine potential effects of mirabegron on vascular function, including brachial artery flow-mediate dilatation; MRI assessment of lower limb blood flow, tissue perfusion and arterial stiffness and numbers and angiogenesis potential of endothelial progenitor cells. Given that mirabegron is safe and clinically available for alternative purposes, a positive study is positioned to immediately impact patient care.. The STAR-PAD trial is approved by the Northern Sydney Local Health District Human Research Ethics Committee (HREC/18/HAWKE/50). The study results will be published in peer-reviewed medical or scientific journals and presented at scientific meetings, regardless of the study outcomes.. ACTRN12619000423112; Results.

Topics: Acetanilides; Clinical Trials, Phase II as Topic; Double-Blind Method; Humans; Multicenter Studies as Topic; Peripheral Arterial Disease; Physical Functional Performance; Quality of Life; Randomized Controlled Trials as Topic; Receptors, Adrenergic, beta-3; Thiazoles; Walking