The Effect of Anacetrapib on Vascular Function and Arterial Stiffness

Vascular Disease Clinical Trial

— REVEAL-Vasc  

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]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931188
• Other study ID #: REVEAL-Vasc
• Status: Completed
• Start date: January 2017
• Est. completion date: May 2018

Study information

• Verified date: February 2024
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Clinical Investigation Ward, Addenbrooke's Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	British Heart Foundation Cambridge Centre of Excellence

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The analysis of low density lipoproteins, high density lipoproteins, total cholesterol and triglycerides (amongst other analytes) from collected blood samples	As a measure of treatment on lipid profile	Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
Primary	The effect of treatment on flow-mediated dilation (FMD)	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	The effect of treatment on aortic (carotid-to-femoral) Pulse Wave Velocity (PWV)	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)
Secondary	The effect of treatment on central blood pressure	As a measure of central haemodynamics	Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)
Secondary	The effect of treatment on sublingual glyceryl trinitrate (GTN) response on artery dilation	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)

External Links

•   REVEAL main trial clinicaltrials.gov record