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Design and rational...
Design and rationale of FLAVOUR : A phase IIa efficacy study of the 5-lipoxygenase activating protein antagonist AZD5718 in patients with recent myocardial infarction
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- Prescott, Eva (författare)
- University of Copenhagen,Univ Copenhagen, Bispebjerg Hosp, Dept Cardiol, Copenhagen, Denmark.
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- Pernow, John (författare)
- Karolinska Institutet,Karolinska University Hospital,Karolinska Univ Hosp, Karolinska Inst, Dept Med, Div Cardiol,Heart & Vasc Theme, Stockholm, Sweden.
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- Saraste, Antti (författare)
- Turku University Hospital,Univ Turku, Turku, Finland.;Turku Univ Hosp, Heart Ctr, Turku, Finland.
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- Åkerblom, Axel, 1977- (författare)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi
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- Angerås, Oskar, 1976 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
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- Erlinge, David (författare)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Lund Univ, Dept Clin Sci, Cardiol, Lund, Sweden.;Skane Univ Hosp, Lund, Sweden.
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- Grove, Erik L. (författare)
- Aarhus University Hospital,Aarhus University,Aarhus Univ, Fac Hlth, Dept Clin Med, Aarhus, Denmark.;Aarhus Univ Hosp, Dept Cardiol, Aarhus, Denmark.
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- Hedman, Marja (författare)
- Kuopio University Hospital,Kuopio Univ Hosp, Heart Ctr, Dept Cardiothorac Surg, Kuopio, Finland.
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- Jensen, Lisette O. (författare)
- Odense University Hospital,Odense Univ Hosp, Dept Cardiol, Odense, Denmark.
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- Svedlund, Sara (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi, sektionen för fysiologi,Institute of Neuroscience and Physiology, Department of Physiology
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- Kjaer, Magnus (författare)
- AstraZeneca, BioPharmaceut R&D, Data Sci & AI, Early Biometr & Stat Innovat, Gothenburg, Sweden.
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- Lagerström-Fermér, Maria (författare)
- AstraZeneca, BioPharmaceut R&D, Cardiovasc Renal & Metab, Res & Early Dev, Gothenburg, Sweden.
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- Gan, Li-Ming, 1969 (författare)
- Univ Gothenburg, Dept Mol & Clin Med, Sahlgrenska Acad, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.;AstraZeneca, BioPharmaceut R&D, Cardiovasc Renal & Metab, Res & Early Dev, Gothenburg, Sweden.,Sahlgrenska University Hospital
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University of Copenhagen Univ Copenhagen, Bispebjerg Hosp, Dept Cardiol, Copenhagen, Denmark (creator_code:org_t)
- Elsevier BV, 2020
- 2020
- Engelska.
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Ingår i: Contemporary Clinical Trials Communications. - : Elsevier BV. - 2451-8654. ; 19
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://doi.org/10.1...
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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http://kipublication...
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https://urn.kb.se/re...
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https://gup.ub.gu.se...
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Abstract
Ämnesord
Stäng
- 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 E4 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- 5-Lipoxygenase activating protein
- Coronary flow reserve
- Coronary flow velocity reserve
- Echocardiography
- Leukotrienes
- Myocardial infarction
- 5-Lipoxygenase activating protein
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
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- Av författaren/redakt...
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Prescott, Eva
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Pernow, John
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Saraste, Antti
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Åkerblom, Axel, ...
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Angerås, Oskar, ...
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Erlinge, David
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visa fler...
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Grove, Erik L.
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Hedman, Marja
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Jensen, Lisette ...
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Svedlund, Sara
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Kjaer, Magnus
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Lagerström-Fermé ...
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Gan, Li-Ming, 19 ...
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Lunds universitet
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Karolinska Institutet
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