The Effect of Anacetrapib on Vascular Function and Arterial Stiffness (REVEAL-Vasc)

February 6, 2024 updated by: Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust

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]

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

103

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Clinical Investigation Ward, Addenbrooke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants for this sub-study will be recrited from the HPS3/TIMI 55- REVEAL trial (NCT01252953).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anacetrapib
Participants who received anacetrapib, in addition to statin on the HPS3/TIMI 55: REVEAL trial.
Drug: Anacetrapib
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
Drug: Statin
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
Placebo
Participants who received placebo, in addition to statin on the HPS3/TIMI 55: REVEAL trial.
Drug: Statin
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
Drug: Placebo
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
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
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
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
Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

British Heart Foundation Cambridge Centre of Excellence

Investigators

  • Principal Investigator: Joseph Cheriyan, MBCHB, MA, FRCP, Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

October 10, 2016

First Posted (Estimated)

October 12, 2016

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REVEAL-Vasc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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