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Arthritis, RheumatoidNCT03625089

Impact of Nurse-led Programme With Carotid Ultrasound on Addressing Cardiovascular Risk in Patients With Arthritis

A study testing Atorvastatin in people with Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Elevated CVD risk is a significant public health problem that contributes greatly to the increased morbidity and shortened lifespan of individuals with RA and PsA. Over the past decades, there has been great progress into the understanding of the severity of CVD risk in these patients but these risk factors are not… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis, Rheumatoid, Arthritis, Psoriatic
What is being tested?
Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteHong Kong
Study dates
1 Sep 2018to 30 Sep 2020
Phase
Interventional
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with RA fulfilled the 2010 ACR/EULAR classification criteria or PsA fulfilled the Classification of Psoriatic Arthritis (CASPAR) criteria
  • aged between 18 and 75 will be recruited.

Who cannot join

  • had a history of overt CVD (ie, symptomatic coronary artery disease [CAD] or ischemic stroke or transient ischemic attack or peripheral vascular disease)
  • had significant co-morbidities including severe renal impairment or severe deranged liver function
  • female of childbearing potential who are unwilling to use adequate contraception, pregnant or breastfeeding women
  • patients who are already taking lipid lowering therapy.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Department of Medicine and Therapeutics

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The Impact of Nurse-led Programme With and Without Carotid Ultrasound on Addressing Cardiovascular Risk in Patients With Arthritis: a Prospective, Multicentre, Randomised, Controlled Trial

Elevated CVD risk is a significant public health problem that contributes greatly to the increased morbidity and shortened lifespan of individuals with RA and PsA. Over the past decades, there has been great progress into the understanding of the severity of CVD risk in these patients but these risk factors are not well managed. The development of the high-risk strategy is therefore necessary, with more intensive therapy reserved for patients identified as high-risk, e.g. because they have high-risk FRS. However, these risk scores under-estimated CV risk in patients with RA and PsA. An intermediate approach is to use quantification of preclinical vascular disease to further identify high-risk patients. Results from this study will provide clinical implications in terms of detecting and managing cardiovascular morbidity in patients with RA and PsA.

Read the detailed description

Objectives This study investigates the impact of a nurse-led programme on cardiovascular (CV) risk screening with and without carotid ultrasound for carotid plaque on CV risk factor control in asymptomatic rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.

Hypothesis The investigators hypothesize that CV risk stratification and management in RA and PsA may be improved by incorporation of carotid ultrasound to assess for carotid plaque.

Being tested
Atorvastatin
Keywords
Carotid Atherosclerosis, Arterial Stiffness, Cardiovascular Risk
Medical subject headings
Arthritis, Rheumatoid, Arthritis, Psoriatic, Carotid Artery Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called Lipitor

    Group 1 patients will be prescribed statin when FRS > 10%; while group patients will be prescribed statin upon presence of carotid plaque as reported from carotid ultrasound. The decision will solely be made base on the randomized group by either FRS>10% or presence of carotid plaque.

    Atorvastatin 20 mg is recommended as the preferred initial high intensity statin to use because it is clinically and cost effective for the primary prevention of CVD according to the national institute for Health and Care Excellence (NICE) guideline from the United Kingdom.

Study groups in NCT03625089
Study groupRoleWhat they receive
Group 1 - FRS armActive comparatorBoth group will participate in the nurse-led programme on CV risk screening and carotid ultrasound for carotid plaque assessment. Subjects in group 1 will initiate Atorvastatin treatment (20mg daily per oral) if their Framingham Risk Score >10%
Receives: Drug: Atorvastatin
Group 2 USG armExperimentalSubjects in group 2 will initiate Atorvastatin treatment (20mg daily per oral) if they had carotid plaque upon carotid ultrasound findings..
Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in Framingham risk score

    The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more. Change in Framingham risk score between subject in two group will be evaluated. A positive change in score indicates increased CV risk, vice versa.

    Measured: 12 months

Secondary outcomes (7)

  1. Change in pulse wave velocity (PWV) in subjects

    Change in arterial stiffness in terms of PWV (cm/s) in subjects between subject in two group, as a parameter to capture change in CV risk upon intervention

    Measured: 12 months

  2. Change in augmentation index (AIX) in subjects

    Change in arterial stiffness in terms of AIX (%)in subjects between subject in two group, as a parameter to capture change in CV risk upon intervention

    Measured: 12 months

  3. Change in individual modifiable risk factors levels

    Target for individual modifiable risk factor will be set (For subject with diabetes, target is Hba1c<7.0%; for dyslipidaemia subject, target is LDL<2.6 mmol/l; for obese subject, target is drop in BMI for 1 unit; for smoker, target is smoking cessation; for all subject, physical activity level target is at least once per week with not less than 30 min activity) Change total number of modifiable risk factor achieved target will be computed.

    Measured: 12 months

  4. The number of measures taken against comorbidities

    The number of measures taken against commodities (including home blood pressure monitoring, attending dietitian education class, compliance to drug etc) after implementation of nurse led clinic

    Measured: 12 months

  5. Proportions of patients achieving remission

    Proportions of patients achieving remission between two group to evaluate outcome upon treat-to-target protocol

    Measured: 12 months

  6. Changes in intima-media thickness (IMT)

    Changes in IMT (mm) in subjects between 2 groups after intervention by using high-resolution ultrasound

    Measured: 12 months

  7. Proportion of plaque progression

    Proportion of plaque progression in subjects between 2 groups after intervention by using high-resolution ultrasound.

    Plaque progression defined as increase in area harboring plaque or increased number of plaque

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start1 Sep 2018 (estimated)
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion30 Sep 2020 (estimated)

Why it stopped: Limited funding support

Resources

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625089
Sponsor's protocol ID
IA_2017
Status last verified
Jul 2019
First submitted
4 Jul 2018
Last updated
25 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Atorvastatin in people with Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Chinese University of Hong Kong at 1 site in Hong Kong.

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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in Framingham risk score (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625089.

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 25 Jul 2019.

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