TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis - TRACE RA

Phase 1

• Conditions: Rheumatoid arthritis is associated with increased mortality from cardiovascular disease (CVD). Statins have a proven effect in reducing CVD events in at-risk populations, mostly due to their cholesterol-lowering properties, but possibly through anti-inflammatory and immunomodulatory effects. This trial will assess the hypothesis that atorvastatin is more effective than placebo in the primary prevention of cardiovascular events in patients with RA.

• Registration Number: EUCTR2006-006032-22-GB
• Lead Sponsor: niversity of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5350

Inclusion Criteria

•Patients who satisfy 1987 ACR classification criteria for RA applied cumulatively [71]
•Age =50 years old OR =10 years of RA disease duration
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Standard Contra-indications to statin therapy:
1)Pregnancy, breast-feeding or women of child-bearing potential not using adequate contraception
2)Known atherosclerotic disease i.e. previous episodes of confirmed Acute Coronary Syndrome (ACS), unstable angina; myocardial infarction with or without ST elevation; or stable CHD/CVD deemed to require statin therapy on clinical grounds, including:
2a) Previous amputation due to severe peripheral vascular disease or severe peripheral arterial disease
2b) Previous central or peripheral revascularisation procedure (including coronary angioplasty, coronary artery bypass graft surgery, peripheral arterial graft surgery)
2c) Accelerated hypertension, severe heart failure (class III or IV), significant dysrhythmia or angina requiring hospitalisation in the 6 months preceding potential study entry
2d) Uncontrolled hypertension (treated or untreated) defined as systolic blood pressure > 200 mmHg and/or diastolic blood pressure > 110 mmHg (identified as the disappearance of all sound (Korotkoff Phase V) after sitting quietly for at least 3 min)
2e) Previous cerebrovascular accident
2f) Other accepted indication for statin therapy according to the investigators¡ current clinical practice
2g)Known familial hyperlipidaemia requiring drug therapy
2h)Known diabetes
3a)Known primary muscle disease
3b)Known hypersensitivity or intolerance to statins
3c)Active liver disease or hepatic dysfunction with AST or ALT >2x upper limit of normal (ULN)
3d)Severe renal dysfunction (Creatinine >200 micromol/l)
Creatinine phosphokinase (CK) >3xULN
3e)Uncontrolled hypothyroidism
3f)Taking any of the following medications:
i)Other HMG-CoA reductase inhibitors (unless warranted as add-in therapy for post-endpoint management of study patients. In such a case during the course of the trial, it will be suggested to the managing physician to start initially Atorvastatin at a dose of 10mg daily (or equivalent dose of another statin of their choice).
ii)Drugs known to be associated with rhabdomyolysis in combination with HMG-CoA reductase inhibitors (e.g. ciclosporin, erythromycin, azo anti-fungals, protease inhibitors and all macrolides)
iii)Drugs (other than beta-blockers, diuretics, ACE inhibitors, other anti-hypertensive agents, oral hypoglycaemic agents and thyroxine replacement therapy) known to affect lipid levels, that interact with the study medications, or that may affect clinical laboratory parameters (such as isotretinoin).
iv)Lipid-regulating drugs: probucol, fibrates and derivatives, bile acid sequestering resins. Patients currently taking a lipid-altering drug may be considered for screening after a 4-week wash-out period except in the case of probucol where medication must have been discontinued for at least 6 months.
v)Drinking more than 1 240ml glass of grapefruit juice per day
4)Participation in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study
5)Other serious illness or significant abnormalities th

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified