Cardiovascular Risk FactorPhase 2P-VECTNCT04181749
Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT Angiography
A Phase 2 study testing aspirin and atorvastatin in people with Cardiovascular Risk Factor, run by University of Leicester at 3 sites in United Kingdom.
Trial summary
The P-VECT Study proposes to test the use of CCTA-derived FAI measurements in a group of patients with coronary artery inflammation, who will receive routinely-used statin and aspirin treatment. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- aspirin and atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 18 Nov 2020to 31 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must satisfy the following conditions:
- Male or Female, aged 30 to 80 years,
- CCTA scan showing mild coronary artery plaques (<50% luminal stenosis) with a high FAI value (>70.1 HU) within last 3 months.
- No definite clinical indication for statin treatment (i.e. do not have either cholesterol >6.5 mM, or cholesterol >5.0 mM and QRISK score >10%).
- Clinical equipoise for statin and aspirin treatment, as determined by the local treating physician. In these patients, there is clinical equipoise because routine treatment with aspirin and statin is not mandated by current guidelines, but the presence of minor coronary artery plaques is frequently interpreted by clinicians as an indication for aspirin and statin treatment. Accordingly, some patients in this group typically receive aspirin and statin treatment, whereas others do not.
- Willing and able (in the Investigators opinion) to comply with all study requirements.
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- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of any incidental findings.
- Able to understand both verbal or written English
- -
Who cannot join
- The participant may not enter the study if ANY of the following are known to apply:
- Previous documented history of coronary artery disease requiring treatment. This includes any of the following:
- Acute myocardial infarction Unstable angina Coronary revascularization procedure Clinically significant coronary artery disease diagnosed by invasive or non-invasive testing.
- Known diabetes mellitus
- Definite clinical indication for statin treatment (i.e. has either cholesterol >6.5 mM, or cholesterol >5.0 mM and QRISK score >10%).
- Treatment with aspirin, statin or any prescribed lipid modification therapy in 6 weeks before baseline CCTA
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- Atrial fibrillation (paroxysmal or persistent)
- History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent.
- Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy
- Active treatment with any anti-inflammatory agents (e.g. NSAIDs, corticosteroids)
- Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to screening with no detectable recurrence are allowed)
- Contraindication for aspirin and/or statin therapy
- Severe Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or 220 µmol/l).
- Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3 × the upper limit of normal [ULN] measured on local labs in last 6 months)
- Any clinically significant abnormality identified at the time of screening that, in the opinion of the Investigator, would preclude safe completion of the study.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- Participants who have participated in another research study involving a treatment intervention or an investigational product, in the past 12 weeks.
- Patients unable to understand verbal or written English.
- Contraindication to contract dye for CCTA.
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
University Hospitals of Leicester
Leicester, LE3 9QP
Donna Alexander, 0116 2583839, donna.alexander@uhl-tr.nhs.uk
David Adlam
- Recruiting
Royal Brompton Hospitals Trust
London, SW3 6NP
Ciara Mahon, 07500697686, C.Mahon@rbht.nhs.uk
Edward Nicol
- Recruiting
John Radcliffe Hospital
Oxford, OX3 9DU
Vicky Toghill, 07969 203252
Charalambos Antoniades
About this study
Official title: Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT
The P-VECT Study proposes to test the use of CCTA-derived FAI measurements in a group of patients with coronary artery inflammation, who will receive routinely-used statin and aspirin treatment. The P-VECT Study is a pilot study that will provide the rationale and data for power calculations to enable design of pivotal trials of the clinical effectiveness of FAI.
Read the detailed description
In this research we will study the ability of coronary CT angiography (CCTA)- derived Fat Attenuation Index (FAI) measurements to detect changes in coronary artery inflammation following treatment with atorvastatin and aspirin . CT scan images are used to evaluate the presence of atherosclerotic plaque in the wall of the coronary arteries. The new CCTA technique, FAI, detects and quantifies coronary artery inflammation by analysis of the characteristics of the adipose tissue (fat) around the wall of the artery - the peri-vascular adipose tissue (PVAT) This is a pilot study, involving patients undergoing a clinically indicated CCTA as part of their routine clinical care who are shown (on their scans) to have mild coronary artery plaques (<50% luminal stenosis) with a high FAI value (>70.1 HU). Patients will have 6 visits (one of which screening) with hospital attendance on 3 occasions for blood tests and drug supply. The pilot study will provide the rationale for power calculations from which further studies can be developed to evaluate the clinical effectiveness of FAI.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- aspirin and atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin and atorvastatinDrug
Patients will be randomized and prescribed either no treatment or aspirin 75mg and Atorvastatin 40mg
| Study group | Role | What they receive |
|---|---|---|
| No treatment | No intervention | Patients will not be prescribed aspirin and statin |
| Aspirin and Atorvastatin | Active comparator | Patients prescribed aspirin and atorvastatin Receives: Drug: aspirin and atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate ability of new coronary CT angiogram (CCTA) scan biomarker- Fat Attenuation Index (FAI).
The overall objective is to evaluate the ability of a new cardiac CCTA scan technique, fat attenuation index (FAI), to detect changes in coronary artery perivascular fat inflammation following 8 months treatment with atorvastatin and aspirin medication
Measured: 3year study- Two years recruitment with 8 month patient follow up
Secondary outcomes (5)
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Evaluate this association by measuring the % of change in plasma LDL-c.
Measured: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Evaluate this association by measuring the % of change in plasma HDL-c.
Measured: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Evaluate this association by measuring the % of change in triglycerides.
Measured: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in FAI and plasma biomarkers of inflammation.
Evaluate this association by measuring the % of change in plasma IL-6.
Measured: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in FAI and plasma biomarkers of inflammation.
Evaluate this association by measuring the % of change in plasma high sensitivity C-reactive protein (hsCRP) .
Measured: 3year study- Two years recruitment with 8 month patient follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start18 Nov 2020
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients randomized to No treatment or Aspirin and Statin
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, British Heart Foundation, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- David Adlam, Dr., Principal investigator, University Hospitals of Leicester and University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181749
- Sponsor's protocol ID
- 0719
- Acronym
- P-VECT
- Status last verified
- Dec 2023
- First submitted
- 19 Nov 2019
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-vascular Adipose Tissue Inflammation Evaluated Using Coronary CT
- ClinicalTrials.gov ID
- NCT04181749
- Acronym / sponsor ID
- P-VECT / 0719
- Conditions
- Cardiovascular Risk Factor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University of Oxford, British Heart Foundation, National Institute for Health Research, United Kingdom
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The P-VECT Study proposes to test the use of CCTA-derived FAI measurements in a group of patients with coronary artery inflammation, who will receive routinely-used statin and aspirin treatment. The P-VECT Study is a pilot study that will provide the rationale and data for power calculations to enable design of pivotal trials of the clinical effectiveness of FAI.
Detailed description
In this research we will study the ability of coronary CT angiography (CCTA)- derived Fat Attenuation Index (FAI) measurements to detect changes in coronary artery inflammation following treatment with atorvastatin and aspirin . CT scan images are used to evaluate the presence of atherosclerotic plaque in the wall of the coronary arteries. The new CCTA technique, FAI, detects and quantifies coronary artery inflammation by analysis of the characteristics of the adipose tissue (fat) around the wall of the artery - the peri-vascular adipose tissue (PVAT) This is a pilot study, involving patients undergoing a clinically indicated CCTA as part of their routine clinical care who are shown (on their scans) to have mild coronary artery plaques (<50% luminal stenosis) with a high FAI value (>70.1 HU). Patients will have 6 visits (one of which screening) with hospital attendance on 3 occasions for blood tests and drug supply. The pilot study will provide the rationale for power calculations from which further studies can be developed to evaluate the clinical effectiveness of FAI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients randomized to No treatment or Aspirin and Statin
| Arm | Type | Receives |
|---|---|---|
| No treatment | No intervention | –Patients will not be prescribed aspirin and statin |
| Aspirin and Atorvastatin | Active comparator | Drug: aspirin and atorvastatinPatients prescribed aspirin and atorvastatin |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or Female, aged 30 to 80 years,
- CCTA scan showing mild coronary artery plaques (<50% luminal stenosis) with a high FAI value (>70.1 HU) within last 3 months.
- No definite clinical indication for statin treatment (i.e. do not have either cholesterol >6.5 mM, or cholesterol >5.0 mM and QRISK score >10%).
- Clinical equipoise for statin and aspirin treatment, as determined by the local treating physician. In these patients, there is clinical equipoise because routine treatment with aspirin and statin is not mandated by current guidelines, but the presence of minor coronary artery plaques is frequently interpreted by clinicians as an indication for aspirin and statin treatment. Accordingly, some patients in this group typically receive aspirin and statin treatment, whereas others do not.
- Willing and able (in the Investigators opinion) to comply with all study requirements.
Key exclusion criteria (20 listed)
- The participant may not enter the study if ANY of the following are known to apply:
- Acute myocardial infarction Unstable angina Coronary revascularization procedure Clinically significant coronary artery disease diagnosed by invasive or non-invasive testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin and atorvastatinPatients will be randomized and prescribed either no treatment or aspirin 75mg and Atorvastatin 40mg | Drug | Aspirin and Atorvastatin |
Primary outcome
Evaluate ability of new coronary CT angiogram (CCTA) scan biomarker- Fat Attenuation Index (FAI).
Time frame: 3year study- Two years recruitment with 8 month patient follow up
The overall objective is to evaluate the ability of a new cardiac CCTA scan technique, fat attenuation index (FAI), to detect changes in coronary artery perivascular fat inflammation following 8 months treatment with atorvastatin and aspirin medication
5 secondary outcomes
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in Fat Attenuation Index (FAI) and plasma lipid parameters.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in FAI and plasma biomarkers of inflammation.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Evaluate the association between changes in FAI and plasma biomarkers of inflammation.
Time frame: 3year study- Two years recruitment with 8 month patient follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Adlam, Dr. principal investigator
University Hospitals of Leicester and University of Leicester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aspirin and atorvastatin in people with Cardiovascular Risk Factor, run by University of Leicester at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander (0116 2583839 ext. 3839, donna.alexander@uhl-tr.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate ability of new coronary CT angiogram (CCTA) scan biomarker- Fat Attenuation Index (FAI). (time frame: 3year study- Two years recruitment with 8 month patient follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.