Design and rationale of FLAVOUR: A phase IIa efficacy study of the 5-lipoxygenase activating protein antagonist AZD5718 in patients with recent myocardial infarction.
5-Lipoxygenase activating protein
Coronary flow reserve
Coronary flow velocity reserve
Echocardiography
Leukotrienes
Myocardial infarction
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
06
04
2020
revised:
14
07
2020
accepted:
26
07
2020
entrez:
3
9
2020
pubmed:
3
9
2020
medline:
3
9
2020
Statut:
epublish
Résumé
Patients with coronary artery disease remain at increased risk of recurrent life-threatening cardiovascular events even after adequate guideline-based treatment of conventional risk factors, including blood lipid levels. Inflammation is a critical pathway in the pathogenesis of atherosclerosis and is independently associated with risk of recurrent cardiovascular events. Leukotrienes are potent pro-inflammatory and vasoactive mediators synthesized by leukocytes in atherosclerotic lesions. AZD5718 is a novel antagonist of 5-lipoxygenase activating protein that suppresses leukotriene biosynthesis. FLAVOUR is a phase IIa efficacy and safety study of AZD5718 in patients with myocardial infarction 1-4 weeks before randomization. Stenosis of the left anterior descending coronary artery after percutaneous intervention must be <50%, and Thrombolysis In Myocardial Infarction flow grade must be ≥ 2. Enrolled participants receive standard care plus oral AZD5718 200 mg, 50 mg, or placebo once daily for up to 12 weeks (extended from 4 weeks by protocol amendment). The planned sample size is 100 participants randomized to 12 weeks' treatment. Change in urine leukotriene E
Identifiants
pubmed: 32875138
doi: 10.1016/j.conctc.2020.100629
pii: S2451-8654(20)30113-7
pii: 100629
pmc: PMC7451793
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100629Informations de copyright
© 2020 Published by Elsevier Inc.
Déclaration de conflit d'intérêts
AA, OA, DE and EP have received speaker honoraria and/or consultancy fees from AstraZeneca. ELG has received speaker honoraria and/or consultancy fees from AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Pfizer, MSD, Mundipharma, Portola Pharmaceuticals and Roche, and research grants from Boehringer Ingelheim. AS has received speaker honoraria and/or consultancy fees from AstraZeneca Bayer, Amgen and Novartis, and research grants from AstraZeneca. L-MG is an employee of AstraZeneca and has received research grants from AstraZeneca. MK and ML-F are employees of AstraZeneca. MH, LOJ, JP and SS have nothing to disclose.
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