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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01389388
First received: April 16, 2010
Last updated: July 7, 2011
Last verified: September 2010
History of Changes

April 16, 2010
July 7, 2011
January 2010
December 2013   (final data collection date for primary outcome measure)
Carotid artery cholesterol plaque regression and stabilization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Reduction of plaque area and change of the plaque morphology to less vulnerable for rupture after 18 months with 40 mg Rosuvastatin daily.
Same as current
Complete list of historical versions of study NCT01389388 on ClinicalTrials.gov Archive Site
  • Disease activity and health measures, lipoprotein components and inflammatory biomarkers [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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)
  • Carotid artery cholesterol plaque regression and stabilization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Lipoprotein components: Lipids, apolipoproteins, magnitude and functional measurements of these, for example of HDL
  • Carotid artery cholesterol plaque regression and stabilization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Biomarkers/inflammation parameters
Same as current
Not Provided
Not Provided
 
Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease
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.

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
  • Carotid Artery Plaque
  • Ankylosing Spondylitis
  • Rheumatoid Arthritis
Drug: Rosuvastatin
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 Name: Brand name for Rosuvastatin is Crestor
Experimental: Rosuvastatin intervention
Patients > 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.
Intervention: Drug: Rosuvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
March 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Concomitant statin treatment
  2. Arterial fibrillation or others with chronic irregular heart rhythm (because of CT).

  3. 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

  4. Secondary hyperlipidemia

    • Primary hyperthyroidism
    • Nephrotic syndrome, creatinine > 2 mg/dl
    • Uncontrolled diabetes mellitus (HbA1C > 10 %)
    • Plasma Triglycerides > 6.8 mmol/l

  5. 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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01389388
2009/2219, 2008-005551-20
No
Anne Grete Semb, MD, PhD, Diakonhjemmet Hospital
Diakonhjemmet Hospital
Not Provided
Principal Investigator: Anne G Semb, MD, PhD Diakonhjemmet Hospital
Diakonhjemmet Hospital
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP