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Carotid Artery PlaqueRORAASNCT01389388

Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease

A study testing Rosuvastatin in people with Carotid Artery Plaque and Ankylosing Spondylitis, run by Diakonhjemmet Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) are at greater risk of developing cardiovascular disease. The reason(s) for this have not been well investigated, but there is a general understanding that systemic inflammation plays a part in the increased cardiovascular morbidity and mortality. Read more about this study

Who is it for?
Ages 35 to 80 years
What is being tested?
Rosuvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteNorway
Study dates
Jan 2013to Aug 2013
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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women and men with RA, AS and other inflammatory forms of arthritis, aged 35-80 years.
  • Cholesterol plaques demonstrated in carotid artery by ultrasound.
  • Informed consent.

Who cannot join

  • Concomitant statin treatment
  • Arterial fibrillation or others with chronic irregular heart rhythm (because of CT).
  • Contraindication to statin treatment.
  • Hypersensitivity to statins
  • Liver disease with ASAT/ALAT ≥ twice the upper normal limit
  • Previous statin-induced myopathy or severe hypersensitivity reactions to other statins
Show all 29Show fewer
  • Raised creatinine (because of contrast medium)
  • Pregnancy or breast feeding
  • Fertile women who do not use contraceptives
  • Cyclosporine treatment
  • Treatment with medicinal products that have a known interaction with Rosuvastatin
  • Uncontrolled hypothyroidism defined as TSH > 1.5 times ULN at the first visit (because of the connection between myopathy and hypothyroidism with statin treatment)
  • Creatinine clearance < 30 ml/min and <60 ml/min with a Rosuvastatin dose of 40 mg per day
  • Secondary hyperlipidemia
  • Primary hyperthyroidism
  • Nephrotic syndrome, creatinine > 2 mg/dl
  • Uncontrolled diabetes mellitus (HbA1C > 10 %)
  • Plasma Triglycerides > 6.8 mmol/l
  • Other diseases or treatment that reduces the safety, or treatment with Rosuvastatin which would interfere with the end points of the study
  • Heart failure: NYHA class III B/IV
  • Haemodynamically significant valve defects
  • Established statin treatment
  • Gastrointestinal disease/treatment that can give malabsorption of Rosuvastatin
  • Cancer
  • Severe psychiatric disease
  • Life-threatening ventricular arrhythmias
  • Other medication that increases the risk of rhabdomyolysis
  • Known abuse of alcohol
  • Participation in other studies

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Anne Grete Semb, Department of Rheumatology, Diakonhjemmet hospital

    Oslo, Oslo, NO-0319

Other trials in Norway

About this study

Official title: Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases

Patients with rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) are at greater risk of developing cardiovascular disease. The reason(s) for this have not been well investigated, but there is a general understanding that systemic inflammation plays a part in the increased cardiovascular morbidity and mortality. In spite of the increased risk in these patients, they have not been included as a high risk patient group in cardiovascular prevention guidelines.

The investigators have carried out a cardiovascular study of RA and AS patients, as well as patients with arthritis for the first time. The investigators have demonstrated cholesterol plaques in the carotid artery in some of these patients. Plaques in the carotid artery represent a risk for development of cerebral stroke and are significantly associated with myocardial infarction. These plaques, which are asymptomatic and do not cause haemodynamically significant narrowing, diameter reduction (i.e. operation is not indicated), are vascular atheromatous disease. Therefore, according to prevailing cardiovascular guidelines (SCORE 2007), these patients shall have secondary prevention with a lipid lowering agent with the LDL-cholesterol goal of 1.8 mmol/L and HDL-cholesterol > 1.0 mmol/L for men and > 1.1 mmol/L for women.

Read more

Statins are cholesterol-lowering drugs, and have been shown to reduce the risk of cardiovascular disease significantly. In addition, reduction in the size of coronary plaques has been induced by statins, when the LDL has been reduced to 1.6-1.8 mmol/l. Plaques in the carotid or coronary arteries have not previously been treated and characterized in patients with RA, AS and other inflammatory forms of arthritis.

The aim of this study is to treat patients with cholesterol plaques in the carotid artery with cholesterol-lowering medication, in the form of Rosuvastatin for 18 months, and characterize the effects on the plaques in the carotid and coronary arteries. In addition, the investigators want to clarify the connection between plaques in the carotid and coronary arteries in patients with RA, AS and other inflammatory forms of arthritis.

Being tested
Rosuvastatin
Keywords
Carotid plaques, inflammatory joint disease, statins, inflammation, lipoprotein components
Medical subject headings
Carotid Stenosis, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Inflammation

What participants receive

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

  • RosuvastatinDrug

    Also called Brand name for Rosuvastatin is Crestor

    All the patients who have signed the informed consent will after they have had performed a MCT and possibly SCC with an IVUS, will be give Rosuvastatinuntill their LDL level has reached 1.6-1.8 mmol/l. The objective is that all the participants should have reached 1.6-1.8 mmol/l 3 months after the start of the study. The participants will remain on Rosuvastatin medication for a total of 18 months.

Study groups in NCT01389388
Study groupRoleWhat they receive
Rosuvastatin interventionExperimentalPatients > 70 years will be given Rosuvastatin of 5 mg a day, uptitering the dose until the LDL level of 1.6-1.8 mmol/l has been reached. Patient <70 years, strat on Rosuvastatin 20 mg a day, uptitered to 40 mg a day, with the LDL of 1.6-1.8 mmol/l. -1.8 mmol/l. The objective is that all the participants should have reached a LDL level of 1.6-1.8 mmol/l 3 months after the start of the study. The participants will remain on Rosuvastatin medication for a total of 18 months.
Receives: Drug: Rosuvastatin

What is being measured

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

  1. Carotid artery cholesterol plaque regression and stabilization

    Reduction of plaque area and change of the plaque morphology to less vulnerable for rupture after 18 months with 40 mg Rosuvastatin daily.

    Measured: 18 months

Secondary outcomes (3)

  1. Disease activity and health measures, lipoprotein components and inflammatory biomarkers

    Disease activity and Health status i. Disease activity will be measured by: 28-swollen-joint count, AIMS2, BASDAI ii. Health status will be measured by MHAQ, BASFI, Pain VAS, Fatigue VAS, life quality (HRQoL)

    Measured: 18 months

  2. Carotid artery cholesterol plaque regression and stabilization

    Lipoprotein components: Lipids, apolipoproteins, magnitude and functional measurements of these, for example of HDL

    Measured: 18 months

  3. Carotid artery cholesterol plaque regression and stabilization

    Biomarkers/inflammation parameters

    Measured: 18 months

Timeline

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

  1. First posted8 Jul 2011 (estimated)
  2. Study startJan 2013
  3. Primary completionAug 2013
  4. Study completionAug 2013

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01389388
Sponsor's protocol ID
2009/2219
Other IDs
2008-005551-20, 2008
Acronym
RORAAS
Status last verified
May 2015
First submitted
16 Apr 2010
Last updated
7 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Os HA, Rollefstad S, Gerdts E, Kringeland E, Ikdahl E, Semb AG, Midtbo H. Preclinical cardiac organ damage during statin treatment in patients with inflammatory joint diseases: the RORA-AS statin intervention study. Rheumatology (Oxford). 2020 Dec 1;59(12):3700-3708. doi: 10.1093/rheumatology/keaa190.

    PubMed 32386421

  • Svanteson M, Rollefstad S, Klow NE, Hisdal J, Ikdahl E, Semb AG, Haig Y. Associations between coronary and carotid artery atherosclerosis in patients with inflammatory joint diseases. RMD Open. 2017 Sep 17;3(2):e000544. doi: 10.1136/rmdopen-2017-000544. eCollection 2017.

    PubMed 28955501

  • Ikdahl E, Rollefstad S, Hisdal J, Olsen IC, Pedersen TR, Kvien TK, Semb AG. Sustained Improvement of Arterial Stiffness and Blood Pressure after Long-Term Rosuvastatin Treatment in Patients with Inflammatory Joint Diseases: Results from the RORA-AS Study. PLoS One. 2016 Apr 19;11(4):e0153440. doi: 10.1371/journal.pone.0153440. eCollection 2016.

    PubMed 27093159

  • Ikdahl E, Hisdal J, Rollefstad S, Olsen IC, Kvien TK, Pedersen TR, Semb AG. Rosuvastatin improves endothelial function in patients with inflammatory joint diseases, longitudinal associations with atherosclerosis and arteriosclerosis: results from the RORA-AS statin intervention study. Arthritis Res Ther. 2015 Oct 8;17:279. doi: 10.1186/s13075-015-0795-y.

    PubMed 26445924

  • Rollefstad S, Ikdahl E, Hisdal J, Olsen IC, Holme I, Hammer HB, Smerud KT, Kitas GD, Pedersen TR, Kvien TK, Semb AG. Rosuvastatin-Induced Carotid Plaque Regression in Patients With Inflammatory Joint Diseases: The Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases Study. Arthritis Rheumatol. 2015 Jul;67(7):1718-28. doi: 10.1002/art.39114.

    PubMed 25778850

Questions about this trial

What is this clinical trial studying?

A study testing Rosuvastatin in people with Carotid Artery Plaque and Ankylosing Spondylitis, run by Diakonhjemmet Hospital at 1 site in Norway.

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 3 inclusion and 29 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: finished, as of the sponsor's last update on 7 May 2015. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Carotid artery cholesterol plaque regression and stabilization (time frame: 18 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 NCT01389388, which also lists 5 linked publications.

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 7 May 2015.

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