Atherosclerotic Cardiovascular DiseaseREVEAL-VascNCT02931188
The Effect of Anacetrapib on Vascular Function and Arterial Stiffness
An observational study of Atherosclerotic Cardiovascular Disease and Vascular Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Vascular Disease
- What is being tested?
- Anacetrapib and Statin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2017to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants for this sub-study will be recrited from the HPS3/TIMI 55- REVEAL trial (NCT01252953).
Who may be able to join
- Participants who have been randomised into the HPS3/TIMI 55- REVEAL study (NCT01252953)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Investigation Ward, Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
About this study
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]
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.
Read the 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.
- Being tested
- Anacetrapib, Statin, Placebo
- Keywords
- Vascular Diseases, Lipids, Cholesteryl Ester Transfer Protein (CETP) Inhibition, Anacetrapib, Cardiovascular Disease, Cholesterol
- Medical subject headings
- Atherosclerosis, Vascular Diseases, Inhibition, Psychological, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnacetrapibDrug
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
StatinDrug
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
PlaceboDrug
No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
| Study group | Role | What they receive |
|---|---|---|
| Anacetrapib | Participants who received anacetrapib, in addition to statin on the HPS3/TIMI 55: REVEAL trial. Receives: Drug: Anacetrapib; Drug: Statin | |
| Placebo | Participants who received placebo, in addition to statin on the HPS3/TIMI 55: REVEAL trial. Receives: Drug: Statin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of treatment on flow-mediated dilation (FMD)
Measured by FMD as a surrogate measure of endothelial-dependent vasodilation
Measured: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
Secondary outcomes (3)
The effect of treatment on aortic (carotid-to-femoral) Pulse Wave Velocity (PWV)
Measured by PWV as a surrogate measure of aortic stiffness
Measured: 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
Measured: 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
Measured: Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation Cambridge Centre of Excellence
- Responsible party
- Principal investigator, Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBChB, MA, FRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931188
- Sponsor's protocol ID
- REVEAL-Vasc
- Acronym
- REVEAL-Vasc
- Status last verified
- Feb 2024
- First submitted
- 12 Sep 2016
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT02931188
- Acronym / sponsor ID
- REVEAL-Vasc / REVEAL-Vasc
- Keywords
- Vascular Diseases, Lipids, Cholesteryl Ester Transfer Protein (CETP) Inhibition, Anacetrapib, Cardiovascular Disease, Cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- British Heart Foundation Cambridge Centre of Excellence
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anacetrapib | – | Drug: Anacetrapib, Drug: StatinParticipants who received anacetrapib, in addition to statin on the HPS3/TIMI 55: REVEAL trial. |
| Placebo | – | Drug: Statin, Drug: PlaceboParticipants who received placebo, in addition to statin on the HPS3/TIMI 55: REVEAL trial. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for this sub-study will be recrited from the HPS3/TIMI 55- REVEAL trial (NCT01252953).
Key inclusion criteria (1 listed)
- Participants who have been randomised into the HPS3/TIMI 55- REVEAL study (NCT01252953)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnacetrapibNo drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953) | Drug | Anacetrapib |
| StatinNo drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953) | Drug | Anacetrapib, Placebo |
| PlaceboNo drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953) | Drug | Placebo |
Primary outcome
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- REVEAL main trial clinicaltrials.gov recordLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cheriyan, MBChB, MA, FRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerotic Cardiovascular Disease and Vascular Disease, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.