PsA T2T Statin Trial on Carotid and Coronary Atherosclerosis

Launched by CHINESE UNIVERSITY OF HONG KONG · Nov 22, 2019

Keywords

ClinConnect Summary

Treatment protocol This is a 1-year prospective, hospital-based, open-label, randomized, controlled trial. The trial comprised two arms. Group 1 will receive T2T strategy together with rosuvastain 20mg daily (T2T-statin group). Group 2 will receive T2T strategy only (T2T-only group). The method of concealed random allocation will be used. Simple randomization will be conducted by a computer-generated random list.

Use of statins The patients will be given the necessary number of rosuvastatin tablets at each visit. At the following visits, surplus medication will be returned to the investiga...

Gender

ALL

Eligibility 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.