The Effect of Anacetrapib on Vascular Function and Arterial Stiffness

NCT02931188 | Completed

• 1 other identifier: REVEAL-Vasc
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease; Vascular Disease

Keywords

Vascular Diseases; Lipids; Cholesteryl Ester Transfer Protein (CETP) Inhibition; Anacetrapib; Cardiovascular Disease; Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• The effect of treatment on central blood pressure

  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

  Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

Other Outcomes (1)

• The analysis of low density lipoproteins, high density lipoproteins, total cholesterol and triglycerides (amongst other analytes) from collected blood samples

  Visits 0-1 (day 0 up to approximately day 28 depending on scheduling of visits)

Study Arms (2)

Anacetrapib

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

Drug: Anacetrapib; Drug: Statin

Placebo

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

Drug: Statin; Drug: Placebo

Interventions

Anacetrapib DRUG

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

Anacetrapib

Statin DRUG

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

Anacetrapib; Placebo

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants for this sub-study will be recrited from the HPS3/TIMI 55- REVEAL trial (NCT01252953).

You may qualify if:

• Participants who have been randomised into the HPS3/TIMI 55- REVEAL study (NCT01252953)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• British Heart Foundation Cambridge Centre of Excellence: collaborator

Study Sites (1)

Clinical Investigation Ward, Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Links

• REVEAL main trial clinicaltrials.gov record

Biospecimen

Retention: SAMPLES WITHOUT DNA

15ml blood samples will be collected from each participant at visit 1.

MeSH Terms

Conditions

Atherosclerosis; Vascular Diseases; Inhibition, Psychological; Cardiovascular Diseases

Interventions

anacetrapib; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Behavior

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Joseph Cheriyan, MBChB, MA, FRCP

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Clinical Pharmacologist & Physician/Associate Lecturer

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: October 12, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

GB (1)