The Effect of Anacetrapib on Vascular Function and Arterial Stiffness

NCT ID: NCT02931188

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Atherosclerotic Cardiovascular Disease Vascular Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Anacetrapib

Participants who received anacetrapib, in addition to statin on the HPS3/TIMI 55: REVEAL trial.

Anacetrapib

Intervention Type DRUG

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

Statin

Intervention Type DRUG

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.

Statin

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

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

Interventions

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Anacetrapib

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

Intervention Type DRUG

Statin

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation Cambridge Centre of Excellence

UNKNOWN

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Joseph Cheriyan, MD

Consultant Clinical Pharmacologist & Physician/Associate Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Cheriyan, MBChB, MA, FRCP

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospitals NHS Foundation Trust

Locations

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Clinical Investigation Ward, Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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REVEAL-Vasc

Identifier Type: -

Identifier Source: org_study_id

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