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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis

NCT01337388

Rheumatoid Arthritis

COMPLETED

Safety and Tolerability of Anti-IL-20 in Subjects With Rheumatoid Arthritis

NCT01038674

Inflammation Rheumatoid Arthritis

COMPLETED PHASE1

Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)

NCT02858492

Arthritis, Rheumatoid

COMPLETED PHASE2

INCB047986 in Rheumatoid Arthritis

NCT02151474

Rheumatoid Arthritis

TERMINATED PHASE2

The Anti-Inflammatory And Metabolic Effects Of Rosiglitazone In Subjects With Rheumatoid Arthritis

NCT00379600

Arthritis, Rheumatoid

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Artery Plaque Ankylosing Spondylitis Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Brand name for Rosuvastatin is Crestor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No