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| Name | Class |
|---|---|
| British Heart Foundation Cambridge Centre of Excellence | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anacetrapib | Participants who received anacetrapib, in addition to statin on the HPS3/TIMI 55: REVEAL trial. |
| |
| Placebo | Participants who received placebo, in addition to statin on the HPS3/TIMI 55: REVEAL trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anacetrapib | Drug | No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| The effect of treatment on central blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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Participants for this sub-study will be recrited from the HPS3/TIMI 55- REVEAL trial (NCT01252953).
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Cheriyan, MBChB, MA, FRCP | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Ward, Addenbrooke's Hospital | Cambridge | Cambridgeshire | CB2 0QQ | United Kingdom |
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| Label | URL |
|---|---|
| REVEAL main trial clinicaltrials.gov record | View source |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D014652 | Vascular Diseases |
| D007266 | Inhibition, Psychological |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C530884 | anacetrapib |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
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15ml blood samples will be collected from each participant at visit 1.
| Statin | Drug | No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953) |
|
| Placebo | Drug | No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953) |
|
As a measure of central haemodynamics |
| 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 | 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) |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |