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NCT Number: NCT01389388

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

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.

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.

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Key information

Conditions

Carotid Artery Plaque Ankylosing Spondylitis Ankylosis Arterial Occlusive Diseases Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Connective Tissue Diseases Immune System Diseases Inflammation Joint Diseases Musculoskeletal Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anne Grete Semb, Department of Rheumatology, Diakonhjemmet hospital

Oslo, NO-0319, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Rosuvastatin

Drug

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.

Other names: Brand name for Rosuvastatin is Crestor

Primary outcomes

  1. Carotid artery cholesterol plaque regression and stabilization

    Time frame: 18 months

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

Secondary outcomes

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

    Time frame: 18 months

    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)

  2. Carotid artery cholesterol plaque regression and stabilization

    Time frame: 18 months

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

  3. Carotid artery cholesterol plaque regression and stabilization

    Time frame: 18 months

    Biomarkers/inflammation parameters

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Official study title

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

Acronym: RORAAS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 8, 2011
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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