Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
7297 participants
INTERVENTIONAL
2007-06-30
2015-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
As of May 2013, 7300 patients had been randomised, and had accrued an average 4.2 years of follow up by the end of May 2014.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Arginine Supplementation to Improve Cardiovascular and Endothelial Function After NSAID Treatment
NCT04765644
Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease
NCT06342609
ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes
NCT06469528
Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk
NCT04774159
The ASPECT Study - Asian Paclitaxel-Eluting Stent Clinical Trial
NCT00196079
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The present proposal seeks to compare the cardiovascular and gastrointestinal safety and effectiveness of a strategy of initial randomisation to treatment with the selective COX-2 inhibitor celecoxib or to 'usual-care' with their current non-selective NSAID therapy (with or without cyto-protection with ulcer healing drug use in either celecoxib or 'usual-care' limbs).
Trial Design
This trial utilises the Prospective Randomised Open Blinded End point (PROBE) design . Patients with clinically diagnosed osteoarthritis (OA) or rheumatoid arthritis (RA) 60 years of age or more who are free from established cardiovascular disease and who require chronic NSAID therapy will be identified in the setting of primary care. Patients will be randomised to receive either celecoxib or to continue their previous standard NSAID therapy. They will then be followed up for an average of 4.2 years in the setting of the local National Healthcare system. The study will terminate when 277 adjudicated cardiovascular events have accrued. A summary is shown in the diagram below.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Celecoxib
Celecoxib. Celebrex 200-400mg daily in divided doses
Celecoxib
200-400mg daily in divided doses
Diclofenac
continue usual nsNSAID
Diclofenac
prescribed medication taken orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Celecoxib
200-400mg daily in divided doses
Diclofenac
prescribed medication taken orally
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chronic NSAIDs use for 90 days or more in a 12 month period
* Subjects who have a licensed indication for chronic non-selective NSAID or Celecoxib.
* Eligible for treatment with either Celecoxib or alternative traditional non-selective NSAID.
* Subjects who are willing to consent to their paper and electronic medical records and prescribing data to be accessed.
* Subjects who are willing to be contacted and interviewed by trial investigators.
Exclusion Criteria
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Glasgow
OTHER
University of Nottingham
OTHER
University of Dundee
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas M MacDonald, MD MRCP FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
Ian Ford, FRCP FRSE
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Christopher J Hawkey, MRCP DM FRC
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Southern Denmark
Odense, , Denmark
Julius Clinical Research
Zeist, , Netherlands
University of Aberdeen
Aberdeen, , United Kingdom
University of Birmingham
Birmingham, , United Kingdom
University of Dundee
Dundee, , United Kingdom
University of Edinburgh
Edinburgh, , United Kingdom
University of Glasgow
Glasgow, , United Kingdom
NHS Highlands
Inverness, , United Kingdom
University of Nottingham
Nottingham, , United Kingdom
University of Oxford
Oxford, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7. doi: 10.1097/00005344-200605001-00017.
MacDonald TM, Hawkey CJ, Ford I, McMurray JJV, Scheiman JM, Hallas J, Findlay E, Grobbee DE, Hobbs FDR, Ralston SH, Reid DM, Walters MR, Webster J, Ruschitzka F, Ritchie LD, Perez-Gutthann S, Connolly E, Greenlaw N, Wilson A, Wei L, Mackenzie IS. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib: the Standard care vs. Celecoxib Outcome Trial (SCOT). Eur Heart J. 2017 Jun 14;38(23):1843-1850. doi: 10.1093/eurheartj/ehw387.
Jennings CG, MacDonald TM, Wei L, Brown MJ, McConnachie L, Mackenzie IS. Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants? Trials. 2015 Mar 7;16:80. doi: 10.1186/s13063-015-0582-8.
Macdonald TM, Mackenzie IS, Wei L, Hawkey CJ, Ford I; SCOT study group collaborators. Methodology of a large prospective, randomised, open, blinded endpoint streamlined safety study of celecoxib versus traditional non-steroidal anti-inflammatory drugs in patients with osteoarthritis or rheumatoid arthritis: protocol of the standard care versus celecoxib outcome trial (SCOT). BMJ Open. 2013 Jan 29;3(1):e002295. doi: 10.1136/bmjopen-2012-002295.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCOT Trial
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.