The Effect of Anacetrapib on Vascular Function and Arterial Stiffness

Completed

• Conditions: Atherosclerotic Cardiovascular Disease; Vascular Disease
• Interventions: Drug: Statin; Drug: Anacetrapib; Drug: Placebo

• Registration Number: NCT02931188
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-10-10
• Study First Posted: 2016-10-12
• Study Start: 2017-01
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Statin	Participants who received placebo, in addition to statin on the HPS3/TIMI 55: REVEAL trial.
Anacetrapib	Statin	Participants who received anacetrapib, in addition to statin on the HPS3/TIMI 55: REVEAL trial.
Placebo	Placebo	Participants who received placebo, in addition to statin on the HPS3/TIMI 55: REVEAL trial.
Anacetrapib	Anacetrapib	Participants who received anacetrapib, in addition to statin on the HPS3/TIMI 55: REVEAL trial.

Primary Outcome Measures

Name	Time	Method
The effect of treatment on flow-mediated dilation (FMD)	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

Name	Time	Method
The effect of treatment on aortic (carotid-to-femoral) Pulse Wave Velocity (PWV)	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
The effect of treatment on central blood pressure	Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)	As a measure of central haemodynamics
The effect of treatment on sublingual glyceryl trinitrate (GTN) response on artery dilation	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

Trial Locations

Locations (1)

Clinical Investigation Ward, Addenbrooke's Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom