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The Standard Care Versus Celecoxib Outcome Trial

Information source: University of Dundee
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis

Intervention: Celecoxib (Drug); non-selective Non steroidal anti inflammatory Drug (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: University of Dundee

Official(s) and/or principal investigator(s):
Thomas M MacDonald, MD MRCP FRCP, Principal Investigator, Affiliation: University of Dundee
Ian Ford, FRCP FRSE, Principal Investigator, Affiliation: University of Glasgow
Christopher J Hawkey, MRCP DM FRC, Principal Investigator, Affiliation: University of Nottingham


The Standard Care versus Celecoxib Outcome Trial (SCOT) is a large streamline safety study designed to compare the cardiovascular safety of celecoxib versus traditional non-selective Non Steroidal Anti-Inflammatory Drug (NSAID) therapy. Traditional NSAID's are associated with significant morbidity and mortality from gastrointestinal toxicity. Cyclooxygenase 2 (Cox-2)selective agents are associated with reduced upper gastrointestinal toxicity. Traditional NSAID's and Cox-2 inhibitors may also be associated with cardiovascular and renal disorders. Data from both randomised and observational studies suggest that celecoxib has similar or reduced cardiovascular toxicity when compared to traditional NSAID's. However, the overall safety balance of a strategy of celecoxib therapy versus a strategy of NSAID therapy is unknown. The European Medicines Evaluation Agency (EMEA) has requested that studies of the cardiovascular safety of celecoxib be carried out within the indicated population of Europe. This study addresses these issues by comparing the cardiovascular safety of celecoxib therapy with traditional NSAID therapy in the setting of the EU healthcare system. 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.

Clinical Details

Official title: Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: To compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.

Secondary outcome: Is to demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.

Detailed description: Aims 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.


Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Subjects 60 years or over Male & Female

- 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


- 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:

- Established cardiovascular disease including ischaemic heart disease, Myocardial

Infarction, angina or acute coronary syndrome, cerebrovascular disease or cerebrovascular accident or transient ischaemic attack, established peripheral vascular disease and moderate to severe heart failure.

Locations and Contacts

University of Southern Denmark, Odense 5000, Denmark

Julius Clinical Research, Zeist 3703 CD Zeist, Netherlands

University of Aberdeen, Aberdeen AB25 2ZN, United Kingdom

University of Birmingham, Birmingham B15 2TT, United Kingdom

University of Dundee, Dundee DD1 9SY, United Kingdom

University of Edinburgh, Edinburgh EH4 2XU, United Kingdom

University of Glasgow, Glasgow G11 6NT, United Kingdom

NHS Highlands, Inverness IV2 3JH, United Kingdom

University of Nottingham, Nottingham NG7 2UH, United Kingdom

University of Oxford, Oxford OX1 2ET, United Kingdom

Additional Information

SCOT study website

MEMO website

Related publications:

MacDonald TM. A European's perspective of COX-2 drug safety. J Cardiovasc Pharmacol. 2006;47 Suppl 1:S92-7.

Starting date: June 2007
Last updated: July 3, 2015

Page last updated: August 23, 2015

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