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| [ ...Back to search results ] | [ Print-friendly version ] |
| TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis |
| ISRCTN | ISRCTN41829447 |
| ClinicalTrials.gov identifier | |
| Public title | TRial of Atorvastatin for the primary prevention of Cardiovascular Events in Rheumatoid Arthritis |
| Scientific title | |
| Acronym | TRACE/RA |
| Serial number at source | N/A |
| 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 anticipated start and end dates of this trial have been updated. The previous dates of this trial were: Previous anticipated start date: 01/12/2006 Previous anticipated end date: 01/12/2014 |
| Lay summary | |
| Ethics approval | Ethics approval received from the Southampton and South West Hampshire Research Ethics Committee B on the 20th December 2006 (ref: 06/Q1704/171). |
| Study design | Multicentre, randomised, double blind, placebo controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Rheumatoid arthritis |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 07/08/2007 |
| Anticipated end date | 01/08/2014 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at: http://www.dgoh.nhs.uk/tracera/gp_patientflyer.asp |
| Target number of participants | 3700 (3808 as of 30/04/2008) |
| Interventions | 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. |
| Primary outcome measure(s) |
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 measure(s) |
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. |
| Sources of funding |
1. British Heart Foundation (UK)
2. Arthritis Research Campaign (ARC) (UK) (ref: 16514) 3. Pfizer UK Ltd (UK) |
| Trial website | http://www.dgoh.nhs.uk/tracera |
| Publications | |
| Contact name | Dr George Kitas |
| Address |
Department of Rheumatology
Dudley Group of Hospitals NHS Trust Russells Hall Hospital |
| City/town | Dudley |
| Zip/Postcode | DY1 2HQ |
| Country | United Kingdom |
| Tel | +44 (0)1384 244842 |
| Fax | +44 (0)1384 244808 |
| g.d.kitas@bham.ac.uk | |
| Sponsor | University of Manchester (UK) |
| Address |
University Research Office
Christie Building Oxford Road |
| City/town | Manchester |
| Zip/Postcode | M13 9PL |
| Country | United Kingdom |
| Tel | +44 (0)161 275 2227 |
| Fax | +44 (0)161 275 2445 |
| karen.shaw@manchester.ac.uk | |
| Sponsor website: | http://www.manchester.ac.uk |
| Date applied | 14/06/2006 |
| Last edited | 30/04/2008 |
| Date ISRCTN assigned | 26/07/2006 |
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