Clinical trial NCT02931188: The Effect of Anacetrapib on Vascular Function and Arterial Stiffness
Official title: A Cross-sectional REVEAL Sub-study Evaluating the Effect of Anacetrapib on Vascular Function and Arterial Stiffness [An Investigator Led Sub-study of HPS3/TIMI 55: REVEAL]
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerotic Cardiovascular Disease
Vascular Disease
Keywords: Vascular Diseases
Lipids
Cholesteryl Ester Transfer Protein (CETP) Inhibition
Anacetrapib
Cardiovascular Disease
Cholesterol
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: British Heart Foundation Cambridge Centre of Excellence
First posted: 2016-10-12
Enrollment: 103
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for this sub-study will be recrited from the HPS3/TIMI 55- REVEAL trial (NCT01252953).

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants who have been randomised into the HPS3/TIMI 55- REVEAL study (NCT01252953)

Exclusion Criteria:

* Any concomitant condition that, at the discretion of the investigator, may affect the participant's ability to complete the study or study procedures
* Atrial fibrillation at time of assessment
* Inability to provide informed consent
* Inability to refrain from caffeine containing products for 6 hours prior to study visit
* Inability to refrain from smoking for 2 hours prior to study visit

Primary outcomes:
measure: The effect of treatment on flow-mediated dilation (FMD)
timeFrame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
Secondary outcomes:
measure: The effect of treatment on aortic (carotid-to-femoral) Pulse Wave Velocity (PWV)
timeFrame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
measure: The effect of treatment on central blood pressure
timeFrame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
measure: The effect of treatment on sublingual glyceryl trinitrate (GTN) response on artery dilation
timeFrame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
Other outcomes:
measure: The analysis of low density lipoproteins, high density lipoproteins, total cholesterol and triglycerides (amongst other analytes) from collected blood samples
timeFrame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
Locations:
city: Cambridge
country: United Kingdom
facility: Clinical Investigation Ward, Addenbrooke's Hospital
state: Cambridgeshire
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Joseph Cheriyan, MBChB, MA, FRCP
role: PRINCIPAL_INVESTIGATOR
References: