Plain English Summary
Not provided at time of registration
Study website
Contact information
Type
Scientific
Contact name
Dr George Kitas
ORCID ID
Contact details
Department of Rheumatology
Dudley Group of Hospitals NHS Trust
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
+44 (0)1384 244842
g.d.kitas@bham.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis
Acronym
TRACE/RA
Study hypothesis
The principal research question is to establish whether atorvastatin, used in conjunction with standard therapy for rheumatoid arthritis will protect rheumatoid arthritis sufferers aged 40 years and above from fatal and non-fatal atherosclerotic events.
Please note that as of 30/04/2008 this trial was updated. All changes can be found in the relevant field under the above date. Please also note that the overall trial start and end dates have been updated. The previous dates of this trial were:
Previous overall trial start date: 01/12/2006
Previous overall trial end date: 01/12/2014
Ethics approval(s)
Southampton and South West Hampshire Research Ethics Committee B, 20/12/2006, ref: 06/Q1704/171
Study design
Multicentre randomised double-blind placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Patient information can be found at: http://www.dgoh.nhs.uk/tracera/gp_patientflyer.asp
Condition
Rheumatoid arthritis
Intervention
Patients will be randomised to either the atorvastatin arm (40 mg of atorvastatin oral tablet taken once daily) or placebo arm (placebo atorvastatin oral tablet taken once daily) of the trial.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Atorvastatin
Primary outcome measure
Cardiovascular primary endpoint for all patients: all cardiovascular events (analysed by time to FIRST event) briefly defined as: fatal myocardial infarction, other acute coronary heart disease death, definite or probable hospital-verified non-fatal acute myocardial infarction, resuscitated cardiac arrest, definite silent myocardial infarction verified by an electrocardiogram (ECG), coronary revascularisation procedures, hospital admission for acute coronary syndrome, fatal stroke or peripheral arterial event (using predefined standard definitions) and hospital-verified non-fatal stroke or peripheral atherosclerotic events. The endpoints assessment committee will adjudicate this.
Rheumatology primary outcome (disease activity substudy only): Disease Activity Score 28 (DAS28) at six months, response will be judged using the European League Against Rheumatism (EULAR) response criteria.
Secondary outcome measures
Secondary endpoints for all patients:
1. All-cause mortality
2. Changes in fasting lipids and C-Reactive Protein (CRP)
3. Functional outcome (assessed by the Health Assessment Questionnaire [HAQ] and EuroQoL instrument [EQ5D])
4. Statin safety-related outcomes.
Rheumatology secondary outcomes (disease activity substudy only): Disease-Modifying Anti-Rheumatic Drug (DMARD) changes, DAS28 at years one, two and five.
Not applicable as of 30/04/2008:
Radiological outcome (assessed by the Larsen score in X-rays of hands and wrists - only at year two.
Overall study start date
07/08/2007
Overall study end date
01/08/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 30/04/2008:
1. Patients must satisfy the 1987 ACR criteria for rheumatoid arthritis applied cumulatively
2. Patients must be aged more than 50 or have had RA disease duration for more than 10 years
3. Patients must provide their written informed consent
Previous inclusion criteria:
1. Patients must satisfy the 1987 ACR criteria for rheumatoid arthritis applied cumulatively
2. Patients must be 40 years or older
3. Patients must provide their written informed consent
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
3,700 (3,808 as of 30/04/2008)
Total final enrolment
3002
Participant exclusion criteria
Current exclusion criteria as of 30/04/2008:
1. Patients who are pregnant or women of child-bearing age not using adequate contraception
2. Known primary muscle disorder
3. Known atherosclerotic disease
4. Known familial hyperlipidamia requiring drug therapy
5. Known diabetes
6. Known hypersensitivity or intolerance to statins
7. Active liver disease or hepatic dysfunction with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than two times Upper Limit of Normal (ULN)
8. Severe renal dysfunction (creatinine >150 micromol/l)
9. Creatinine phosphokinase (CK) more than three times ULN
10. Uncontrolled hypothyroidism (defined as any elevation of Thyroid-Stimulating Hormone [TSH] above ULN)
11. Participation in another clinical trial concurrently or within 30 days prior to screening for entry into this study (patients may be participating in an observational study such as the British Society for Rheumatology Biologics register)
12. Other serious illness or significant abnormalities that may compromise the patient's safety or successul participation in the study
13. Any illness which, in the doctor's opinion, means that the patient is unable to give informed consent
14. Known alcohol abuse
Previous exclusion criteria:
1. Patients who are pregnant or women of child-bearing age not using adequate contraception
2. Known primary muscle disorder
3. Known atherosclerotic disease
4. Known familial hyperlipidamia requiring drug therapy
5. Known diabetes
6. Calculated absolute ten year Cardio-Vascular Disease (CVD) risk of 20% or higher, using the Joint British Societies revised risk calculator
7. Known hypersensitivity or intolerance to statins
8. Active liver disease or hepatic dysfunction with Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) more than two times Upper Limit of Normal (ULN)
9. Severe renal dysfunction (creatinine >150 micromol/l)
10. Creatinine phosphokinase (CK) more than three times ULN
11. Uncontrolled hypothyroidism (defined as any elevation of Thyroid-Stimulating Hormone [TSH] above ULN)
12. Participation in another clinical trial concurrently or within 30 days prior to screening for entry into this study (patients may be participating in an observational study such as the British Society for Rheumatology Biologics register)
13. Other serious illness or significant abnormalities that may compromise the patient's safety or successul participation in the study
14. Any illness which, in the doctor's opinion, means that the patient is unable to give informed consent
15. Known alcohol abuse
Recruitment start date
07/08/2007
Recruitment end date
01/08/2014
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Dudley Group of Hospitals NHS Trust
Dudley
DY1 2HQ
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
University Research Office
Christie Building
Oxford Road
Manchester
M13 9PL
England
United Kingdom
+44 (0)161 275 2227
karen.shaw@manchester.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research organisation
Funder name
British Heart Foundation (UK)
Alternative name(s)
the_bhf, The British Heart Foundation, BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Funder name
Arthritis Research Campaign (ARC) (UK) (ref: 16514)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Pfizer UK Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/04/2015 | Yes | No | |
| Results article | results | 01/09/2019 | 06/02/2020 | Yes | No |