Effects of Rosuvastatin on Carotid Artery Plaques in Patients With Inflammatory Joint Disease (RORAAS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Carotid Artery Plaque Ankylosing Spondylitis Rheumatoid Arthritis |
Drug: Rosuvastatin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Cholesterol Plaques in Carotid and Coronary Arteries and the Effect of Rosuvastatin in Rheumatoid Arthritis, Ankylosing Spondylitis and Other Inflammatory Joint Diseases |
- 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.
- 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
| Enrollment: | 114 |
| Study Start Date: | January 2013 |
| Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
|
Eligibility| Ages Eligible for Study: | 35 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01389388
| Norway | |
| Anne Grete Semb, Department of Rheumatology, Diakonhjemmet hospital | |
| Oslo, Norway, NO-0319 | |
| Principal Investigator: | Anne G Semb, MD, PhD | Diakonhjemmet Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Anne Grete Semb, Leader of the Preventive Cardio-Rheuma clinic, Diakonhjemmet Hospital |
| ClinicalTrials.gov Identifier: | NCT01389388 History of Changes |
| Other Study ID Numbers: | 2009/2219 2008-005551-20 |
| Study First Received: | April 16, 2010 |
| Last Updated: | May 6, 2015 |
| Health Authority: | Norway: Norwegian Medicines Agency |
Keywords provided by Diakonhjemmet Hospital:
|
Carotid plaques inflammatory joint disease statins inflammation lipoprotein components |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Carotid Stenosis Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases |
Spondylarthropathies Spondylarthritis Ankylosis Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Rosuvastatin Calcium Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
ClinicalTrials.gov processed this record on September 23, 2016