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

NHS Foundation Trust logo

NHS Foundation Trust

Status

Completed

Conditions

Vascular Disease
Atherosclerotic Cardiovascular Disease

Treatments

Drug: Placebo
Drug: Statin
Drug: Anacetrapib

Study type

Observational

Funder types

Other

Identifiers

NCT02931188
REVEAL-Vasc

Details and patient eligibility

About

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.

Full 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.

Enrollment

103 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

103 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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