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PsA T2T Statin Trial on Carotid and Coronary Atherosclerosis

NCT04176978 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-09-06

No results posted yet for this study

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

Interventions

DRUG

Rosuvastatin

Patient in this group will receive Rosuvastatin 20mg daily.

OTHER

Treat-to-target strategy

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

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Lai Shan Tam, MD · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176978 on ClinicalTrials.gov