Design and rationale of FLAVOUR: A phase IIa efficacy study of the 5-lipoxygenase activating protein antagonist AZD5718 in patients with recent myocardial infarction

: Eva Prescott, John Pernow, Antti Saraste, Axel Åkerblom, Oskar Angerås, David Erlinge, Erik L. Grove, Marja Hedman, Lisette O. Jensen, Sara Svedlund, Magnus Kjaer, Maria Lagerström-Fermér, Li-Ming Gan

Publisher: Elsevier Inc.

: 2020

: Contemporary Clinical Trials Communications

: Contemporary clinical trials communications

: Contemp Clin Trials Commun

: 100629

: 19

: 8

: 2451-8654

DOI: https://doi.org/10.1016/j.conctc.2020.100629

: https://research.utu.fi/converis/portal/detail/Publication/50181904

levels is the primary efficacy outcome. FLAVOUR also aims to evaluate whether AZD5718 can improve coronary microvascular function, as measured by transthoracic colour Doppler-assisted coronary flow velocity reserve. Centrally pretrained study sonographers use standardized protocols and equipment. Additional outcomes include assessment of comprehensive echocardiographic parameters (including coronary flow, global strain, early diastolic strain rate and left ventricular ejection fraction), arterial stiffness, biomarkers, health-related quality of life, and safety. Specific anti-inflammatory therapies may represent novel promising treatments to reduce residual risk in patients with coronary artery disease. By combining primary pharmacodynamic and secondary cardiovascular surrogate efficacy outcomes, FLAVOUR aims to investigate the mechanistic basis and potential benefits of AZD5718 treatment in patients with coronary artery disease.

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