There are currently no studies evaluating the effect of anacetrapib on blood vessel function and stiffness of the arteries. The REVEAL-Vasc trial will assess whether anacetrapib, in addition to atorvastatin (LDL-C lowering drug) treatment, results in greater endothelial-dependent vascular function and aortic stiffness in patients with established cardiovascular disease, compared to adding placebo. Participants will be asked to provide a blood sample and pulse Wave Velocity/Pulse Wave Analysis and Flow Mediated Dilation will be carried out to assess blood vessel function and stiffness of the arteries. REVEAL-Vasc is an investigator led sub-study of HPS3/TIMI 55: REVEAL (Randomized Evaluation of the Effects of Anacetrapib through Lipid modification): A large-scale, randomized placebo-controlled trial of the clinical effects of anacetrapib among people with established vascular disease (NCT01252953) which is coordinated by OXFORD CTSU. No treatment will be received on this sub-study, therefore only participants who have been enrolled in HPS3/TIMI55 REVEAL in which participants received anacetrapib with atorvastatin or placebo will be considered for this trial.
REVEAL-Vasc is an investigator led sub-study of HPS3/TIMI 55: REVEAL. Participants who previously enrolled on HPS3/TIMI 55: REVEAL and received treatment will be invited to participate in this sub-study. Participants will attend a screening and an assessment visit during which Pulse Wave Velocity/ Pulse Wave Analysis and Flow Mediated Dilation will be carried out to assess blood vessel function and stiffness. A blood sample will also be taken from participant to assess CRP and lipid profile. Since participants will have received treatment on the main trial HPS3/TIMI 55: REVEAL, no treatment will be received on this sub-study.
Study Type
OBSERVATIONAL
Enrollment
103
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
Clinical Investigation Ward, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
The effect of treatment on flow-mediated dilation (FMD)
Measured by FMD as a surrogate measure of endothelial-dependent vasodilation
Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
The effect of treatment on aortic (carotid-to-femoral) Pulse Wave Velocity (PWV)
Measured by PWV as a surrogate measure of aortic stiffness
Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
The effect of treatment on central blood pressure
As a measure of central haemodynamics
Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
The effect of treatment on sublingual glyceryl trinitrate (GTN) response on artery dilation
Measured by FMD as a surrogate measure of endothelial-independent vasodilation
Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
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