PsA T2T Statin Trial on Carotid and Coronary Atherosclerosis

NCT04176978 | Withdrawn

• 1 other identifier: CREC 2019.063T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Psoriatic Arthritis; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• change in CIMT over a period of 12 months between two groups

  The change in carotid IMT will be compared between 2 groups. A higher increment indicate greater progression of atherosclerosis

  12 months

Secondary Outcomes (3)

• Progression of carotid plaque at 12 months between the two groups.

  12 months

• Percent change in indexed volume of noncalcified coronary plaque by CCTA over a period of 12 months between the two groups.

  12 months

• Percent change in indexed volume of the sum of fatty plaque and fibrous plaque detected by CCTA over a period of 12 months between the two groups.

  12 months

Study Arms (2)

T2T + statin

EXPERIMENTAL

Patient in this arm will receive treat-to-target strategy with rousavastin 20mg

Drug: Rosuvastatin; Other: Treat-to-target strategy

T2T only

ACTIVE COMPARATOR

Patient in this arm will receive treat-to-target strategy only.

Other: Treat-to-target strategy

Interventions

Rosuvastatin DRUG

Patient in this group will receive Rosuvastatin 20mg daily.

Also known as: Statin

T2T + statin

Treat-to-target strategy OTHER

Patient will receive treat-to-target strategy aiming at minimal disease activity (MDA). If patient cannot achieve MDA, treatment will be escalated.

Also known as: T2T

T2T + statin; T2T only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfilled the Classification of Psoriatic Arthritis (CASPAR) criteria
• With asymptomatic carotid plaques with \<50% stenosis

You may not qualify if:

• History of overt CVD (including myocardial infarction, angina, stroke, and transient ischemic attack)
• Currently on antiplatelet agents (including aspirin, Clopidogrel etc), or HMG-CoA reductase inhibitors (statins);
• FRS \> 10% at screening visit who are indicated to start statins;
• 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
• Female of childbearing potential who are unwilling to use adequate contraception
• Pregnant or breastfeeding women
• Cyclosporine treatment
• Treatment with medicinal products that have a known interaction with rosuvastatin
• Uncontrolled hypothyroidism defined as thyroid-stimulating hormone level of \>1.5 times the ULN at the first visit \[due to the connection between myopathy and hypothyroidism with statin treatment\]
• 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 \[602.3 mg/dl\])
• 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).
• Currently on glucocorticoids at a dose \>10mg/day.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Medicine and Therapeutics

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Arthritis, Psoriatic; Atherosclerosis

Interventions

Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Lai Shan Tam, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: November 26, 2019
• Study Start: April 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)