Investigating the Lowest Threshold of Vascular Benefits from LDL Cholesterol Lowering with a PCSK9 mAb Inhibitor (Alirocumab) in Patients with Stable Cardiovascular Disease (INTENSITY-HIGH): protocol and study rationale for a randomised, open label, parallel group, mechanistic study
| Autor: | Michalis Kostapanos, Elena Hernan Sancho, Carmel M. McEniery, Joseph Cheriyan, Ian B. Wilkinson, Joanna Helmy, Fotini Kaloyirou, Holly Pavey, Evangelia Vamvaka, Paul J. Cacciottolo, Annette Hubsch |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Statin medicine.drug_class Disease Cardiovascular Medicine Systemic inflammation Antibodies Monoclonal Humanized preventive medicine Ezetimibe Internal medicine Positron Emission Tomography Computed Tomography medicine lipid disorders Humans cardiovascular imaging Preventive healthcare Alirocumab Randomized Controlled Trials as Topic Wales business.industry PCSK9 Antibodies Monoclonal General Medicine Cholesterol LDL Cardiovascular Diseases cardiology Good clinical practice Medicine medicine.symptom Hydroxymethylglutaryl-CoA Reductase Inhibitors Proprotein Convertase 9 business medicine.drug |
| Zdroj: | BMJ Open, Vol 11, Iss 4 (2021) BMJ Open |
| ISSN: | 2044-6055 |
| Popis: | IntroductionElevated low-density lipoprotein cholesterol (LDL-C) is a strong independent risk predictor of cardiovascular (CV) events, while interventions to reduce it remain the only evidence-based approach to reduce CV morbidity and mortality. Secondary prevention statin trials in combination with ezetimibe and/or proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors showed that there is no ‘J shaped curve’ in LDL-C levels with regard to CV outcomes. The lowest threshold beyond which reduction of LDL-C confers no further CV benefits has not been identified.The INTENSITY-HIGH study seeks to explore physiological mechanisms mediating CV benefits of LDL-C lowering by PCSK9 inhibition in patients with established cardiovascular disease (CVD). The study examines the changes in measures of endothelial function and vascular inflammation imaging following intervention with PCSK9 and against standard of care.Methods and analysisThis is a single-centre, randomised, open label, parallel group, mechanistic physiological study. It will include approximately 60 subjects with established CVD, with LDL-C of Ethics and disseminationThe study received a favourable opinion from the Wales Research Ethics Committee 4, was registered on clinicaltrials.gov and conformed to International Conference for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice. The results of this study will be reported through peer-reviewed journals and conference presentations.Trial registration numberNCT03355027. |
| Databáze: | OpenAIRE |
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