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Trial in Rheumatoid Arthritis of Lisinopril
DOI 10.1186/ISRCTN30714266
ClinicalTrials.gov identifier
EudraCT number
Public title Trial in Rheumatoid Arthritis of Lisinopril
Scientific title
Acronym TRALIS
Serial number at source TRALIS001
Study hypothesis That the angiotensin converting enzyme (ACE) inhibitor, lisinopril will:
1. Reduce rheumatoid disease activity
2. Improve vascular correlates of active rheumatoid arthritis
Lay summary Not provided at time of registration
Ethics approval Approved by the Trent Multicentre Research Ethics Committee, provisional approval on 13/12/05, reference number: 05/MRE04/93; final approval on 01/02/06
Study design Randomised, double-blind, placebo-controlled, dual arm study
Countries of recruitment United Kingdom
Disease/condition/study domain Rheumatoid arthritis
Participants - inclusion criteria 1. Age ≥18 years and ≤80 years
2. Diagnosis of rheumatoid arthritis
3. Stable dose of disease-modifying anti-rheumatic drug (DMARD) (conventional or biological) over one month preceding the trial
4. Residual disease activity - disease activity score 28 (DAS28) >3.5
5. Use of adequate contraception in females of child-bearing potential
Participants - exclusion criteria 1. Major surgery within six weeks
2. Other systemic inflammatory diseases or inflammatory arthritis (e.g. systemic lupus erythematosus [SLE], scleroderma, vasculitis, spondyloarthropathy, crystal arthropathy)
3. Functional class IV unable to mobilise without assistance from another individual or wheelchair-user
4. Treatment with another investigational agent within four weeks
5. Intra-articular or parenteral corticosteroids within four weeks of screening visit
6. Chronic use of corticosteroid >7.5 mg prednisolone (or equivalent)
7. Variation in dose of corticosteroid <7.5 mg prednisolone (or equivalent) in one month prior to screening visit
8. Current use of ACE inhibitor or angiotensin receptor blocker
9. Allergy to ACE inhibitor or angiotensin receptor blocker
10. Blood pressure (BP) ≤100/60; BP ≥180/100
11. Left ventricular failure
12. Major infective episode requiring hospitalisation or treatment with intravenous (IV) antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening
13. Current solid organ or haematological malignancy
14. Pregnancy or breastfeeding
15. Renal impairment with estimated creatinine clearance of <50 ml/min
16. Aspartate aminotranferase (AST) and alanine aminotransferase (ALT) AST/ALT >100 IU/l
17. Neutrophils <2.0 x 10^9/l, platelets <100 x 10^9/l, haemoglobin <10 g/dl
18. Known lactose intolerance
Anticipated start date 23/01/2006
Anticipated end date 31/12/2008
Status of trial Completed
Patient information material Patient information can be found at: http://www.cambridge-arthritis.org.uk/tralis.php?name=TRALIS
Target number of participants 200
Interventions Treatment with lisinopril 20 mg once daily versus placebo
Primary outcome measure(s) Rheumatoid disease activity score 28 (DAS28)
Secondary outcome measure(s) 1. Swollen joint count
2. Flow-mediated dilatation (FMD)
3. Aortic pulse wave velocity (PWV)
4. Aortic augmentation index (AIx)
5. High sensitivity C-reactive protein
6. Serum cartilage oligomeric matrix protein (marker of cartilage breakdown)
7. Serum soluble intercellular adhesion molecule (ICAM-1) (marker of endothelial activation)
Sources of funding 1. The Evelyn Trust
2. Cambridge Arthritis Research Endeavour (registered charity number: 802862)
Trial website http://www.cambridge-arthritis.org.uk/tralis.php
Contact name Dr  Frances  Hall
  Address Box 157
Department of Clinical Medicine
Addenbrooke's Hospital
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
Sponsor Addenbrooke's NHS Foundation Trust (UK)
  Address Research and Development Department
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
Date applied 19/12/2005
Last edited 08/02/2012
Date ISRCTN assigned 05/04/2006
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