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

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ClinicalTrials.gov Identifier: NCT02931188
Recruitment Status : Completed
First Posted : October 12, 2016
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
British Heart Foundation Cambridge Centre of Excellence
Information provided by (Responsible Party):
Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Atherosclerotic Cardiovascular Disease Vascular Disease Drug: Anacetrapib Drug: Statin Drug: Placebo

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.

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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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]
Actual Study Start Date : January 2017
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
15ml blood samples will be collected from each participant at visit 1.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02931188


Locations
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United Kingdom
Clinical Investigation Ward, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation Cambridge Centre of Excellence
Investigators
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Principal Investigator: Joseph Cheriyan, MBChB, MA, FRCP Cambridge University Hospitals NHS Foundation Trust

Additional Information:
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Responsible Party: Joseph Cheriyan, MD, Consultant Clinical Pharmacologist & Physician/Associate Lecturer, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02931188    
Other Study ID Numbers: REVEAL-Vasc
First Posted: October 12, 2016    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Keywords provided by Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust:
Vascular Diseases
Lipids
Cholesteryl Ester Transfer Protein (CETP) Inhibition
Anacetrapib
Cardiovascular Disease
Cholesterol
Additional relevant MeSH terms:
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Vascular Diseases
Atherosclerosis
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Oxazolidinones
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Anti-Infective Agents
Protein Synthesis Inhibitors