INTENSITY-HIGH
Research type
Research Study
Full title
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).
IRAS ID
222522
Contact name
Joseph Cheriyan
Contact email
Sponsor organisation
Cambridge University Hospitals Foundation Trust and the University of Cambridge
Eudract number
2017-000185-30
Duration of Study in the UK
3 years, 0 months, 3 days
Research summary
INTENSITY-High aims to answer if there are limits to LDL reduction in terms of vascular health, exploring the mechanisms by which secondary prevention in patients with established heart disease may benefit from even lower LDL levels. By using PCSK9 inhibitors such as Alirocumab, very low LDL cholesterol levels not previously encountered in statin trials, can be achieved in patients with established heart disease on top of intensive statin treatment.
This research is being carried out because it is unclear what the lowest threshold of LDL cholesterol should be to attain significant reductions in CV risk in stable cardiovascular patients. It is unknown whether there is a true limit of LDL cholesterol below which there is no further improvement in endothelial function in stable cardiovascular patients, and, whether this is associated with a reduction in markers of both systemic and vascular inflammation.
Defining this may help identify individuals from the general population who may benefit from more aggressive lipid lowering treatment than standard statin treatment in terms of CV morbidity and mortality.
This study will be conducted in patients with stable cardiovascular disease, where they will be randomized to receive either a combination of Alirocumab and statin, or Ezetimibe plus statin. 60 patients will be recruited to this single centre, randomized, open label, parallel group, mechanistic physiological study which will be conducted at Cambridge University Hospitals NHS Foundation Trust. The total study duration for each participant will be approximately 14 weeks. A series of non-invasive vascular studies and medical imaging assessments will be conducted to observe vascular and systemic inflammation and to assess endothelial vascular function.
REC name
Wales REC 4
REC reference
17/WA/0285
Date of REC Opinion
11 Sep 2017
REC opinion
Favourable Opinion