PsA T2T Statin Trial on Carotid and Coronary Atherosclerosis

• Status: Suspended
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Psoriatic arthritis (PsA) is a chronic inflammatory disease associated with an increased risk of myocardial infarction (MI). Using coronary computer tomography angiogram (CCTA), it is found that a significantly higher prevalence of high-risk coronary plaque (non-calcified plaque [NCP]), supporting the notion that more aggressive cardiovascular (CV) evaluation strategy should be considered in these patients.

Carotid ultrasound screening in this population may be a better alternative than traditional risk score to identify patients at high CV risk as the latter underestimated CV risk. Previous study from our group have demonstrated that achieving treatment target (minimal disease activity [MDA]) can prevent progression of carotid atherosclerosis. Nevertheless, 38% of this Treat to Target (T2T) cohort still had carotid plaque progression.

Project description

it is hypothesized that combination of a T2T stratgy together with high-intensity rosuvastatin treatment (Group 1: T2T-statin group) is more effective in preventing progression of coronary and carotid atherosclerosis than T2T stratgy alone (Group 2: T2T-only group) in high-risk PsA patients with carotid plaque.

The primary outcome is to ascertain the effect of T2T strategy with high-intensity rosuvastain (Group 1: T2T-statin group) on the change in CIMT over a period of 12 months compared with T2T strategy alone (Group 2: T2T-only group)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

1. Fulfilled the Classification of Psoriatic Arthritis (CASPAR) criteria

2. With asymptomatic carotid plaques with <50% stenosis

Exclusion Criteria:

1. History of overt CVD (including myocardial infarction, angina, stroke, and transient ischemic attack)

2. Currently on antiplatelet agents (including aspirin, Clopidogrel etc), or HMG-CoA reductase inhibitors (statins);

3. FRS > 10% at screening visit who are indicated to start statins;

4. had contraindication for statin medication (hypersensitivity to statins, liver disease with transaminase levels of ≥ 2 times the upper limit of normal [ULN], previous statin-induced myopathy or severe hypersensitivity, reactions to other statins

5. Female of childbearing potential who are unwilling to use adequate contraception

6. Pregnant or breastfeeding women

7. Cyclosporine treatment

8. Treatment with medicinal products that have a known interaction with rosuvastatin

9. Uncontrolled hypothyroidism defined as thyroid-stimulating hormone level of >1.5 times the ULN at the first visit [due to the connection between myopathy and hypothyroidism with statin treatment]

10. Secondary hyperlipidemia (primary hypothyroidism, nephrotic syndrome, creatinine level of > 120µmol/l], uncontrolled diabetes mellitus [DM] [glycated hemoglobin >10%], or plasma triglyceride level of >6.8 mmoles/liter [602.3 mg/dl])

11. Other diseases or treatment that reduces the safety of rosuvastatin or treatment that would interfere with use of rosuvastatin (gastrointestinal disease/treatment that may cause malabsorption of rosuvastatin, cancer, severe psychiatric disease, life-threatening ventricular arrhythmias, other medication that increases the risk of rhabdomyolysis, known alcohol abuse, or participation in other studies).

12. Currently on glucocorticoids at a dose >10mg/day.