A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24,081
- 试验地点
- 1,040
- 主要终点
- The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
研究概览
简要总结
To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.
排除标准
- •Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
- •Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
- •Subjects require treatment with aspirin > 325 mg /day
- •Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
研究组 & 干预措施
celecoxib
subject receives celecoxib and dummy (placebo) ibuprofen and naproxen
干预措施: celecoxib (Drug)
ibuprofen
subject receives ibuprofen and dummy (placebo) celecoxib and naproxen
干预措施: Ibuprofen (Drug)
naproxen
subject receives naproxen and dummy (placebo) celecoxib and ibuprofen
干预措施: Naproxen (Drug)
结局指标
主要结局
The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
时间窗: Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months
APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).
次要结局
- The First Occurrence of a Major Adverse Cardiovascular Events (MACE)(ITT Population - 30 months; MITT Population - 42 months)
- The First Occurrence of Clinically Significant Gastrointestinal Events (CSGIE)(ITT Population - 30 months; MITT Population - 42 months)
- Change From Baseline in Patient's Assessment of Arthritis Pain (VAS)(ITT and MITT Population - Baseline to 42 months)