Phase 4 Study A Large Streamline Safety Study Designed to Compare the Cardiovascular Safety od Celecoxib Versus Traditional Non-selective NSAID's
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7,297
- 试验地点
- 10
- 主要终点
- compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
NSAID
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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.
排除标准
- •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.
研究组 & 干预措施
Celecoxib
Celecoxib. Celebrex 200-400mg daily in divided doses
干预措施: Celecoxib (Drug)
Diclofenac
continue usual nsNSAID
干预措施: Diclofenac (Drug)
结局指标
主要结局
compare cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
时间窗: 4 years
次要结局
- demonstrate the superiority of celecoxib over traditional NSAIDs on ulcer-related upper gastrointestinal complications.(4 years)