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NCT Number: NCT02931188

The Effect of Anacetrapib on Vascular Function and Arterial Stiffness

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.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Inhibition, Psychological Vascular Disease Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Investigation Ward, Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anacetrapib

Drug

No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)

Statin

Drug

No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)

Placebo

Drug

No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)

Primary outcomes

  1. The effect of treatment on flow-mediated dilation (FMD)

    Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

    Measured by FMD as a surrogate measure of endothelial-dependent vasodilation

Secondary outcomes

  1. The effect of treatment on aortic (carotid-to-femoral) Pulse Wave Velocity (PWV)

    Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

    Measured by PWV as a surrogate measure of aortic stiffness

  2. The effect of treatment on central blood pressure

    Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

    As a measure of central haemodynamics

  3. The effect of treatment on sublingual glyceryl trinitrate (GTN) response on artery dilation

    Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

    Measured by FMD as a surrogate measure of endothelial-independent vasodilation

Other outcomes

  1. The analysis of low density lipoproteins, high density lipoproteins, total cholesterol and triglycerides (amongst other analytes) from collected blood samples

    Time frame: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

    As a measure of treatment on lipid profile

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Collaborators

  • British Heart Foundation Cambridge Centre of Excellence

Registry information

Official study 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]

Acronym: REVEAL-Vasc

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2016
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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