NCT00882388已完成4 期
Phase 4 Study of the Effect of Celecoxib on the Antiplatelet Effect of Aspirin and Clopidogrel
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Light transmittance aggregometry : % of inhibition (ADP, collagen)
研究概览
简要总结
Background:
- The prevalence of arthritis which needs celecoxib prescription is high in patients with coronary artery disease.
- The main concern is that celecoxib would increase thrombogenicity by inhibiting the synthesis of prostacyclin in endothelial cells.
- It is not known whether the administration of celecoxib would deteriorate antiplatelet effects of aspirin and clopidogrel which are used after stenting.
Methods:
- Healthy volunteers (n=40)
- Randomization into five subgroups
- aspirin, celecoxib, aspirin+celecoxib, aspirin+clopidogrel, aspirin+clopidogrel+celecoxib
- Medication schedule : medication of each drug for 6 days, blood samples at day 0 and day 7
- Celecoxib 200mg twice a day, and/or aspirin 100mg daily, and/or clopidogrel 75 mg daily
- Platelet function test : light transmittance aggregometry and arachidonic acid metabolite assay among subgroups.
Study hypothesis : The addition of celecoxib does not deteriorate antiplatelet function of aspirin and clopidogrel.
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
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers including both men and women 20~30 years
- •no abnormality in physical examination, 12-lead ECG, and routine laboratory test
排除标准
- •Subjects with cardiovascular disease, hemostatic disorder, hypersensitivity to NSAIDs and clopidogrel
- •Women with a positive pregnancy test
- •chronic drinkers
- •overweight exceeding 20% of standard body weight
研究组 & 干预措施
ASA
Active Comparator
aspirin only
干预措施: aspirin (Drug)
Cele
Active Comparator
干预措施: celecoxib (Drug)
ASA + Cele
Experimental
干预措施: aspirin + celecoxib (Drug)
ASA + Clo
Active Comparator
干预措施: aspirin + clopidogrel (Drug)
ASA + Clo + Cele
Experimental
干预措施: aspirin + clopidogrel + celecoxib (Drug)
结局指标
主要结局
Light transmittance aggregometry : % of inhibition (ADP, collagen)
时间窗: 7 days
次要结局
- Urine arachidonic metabolite assay(7 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effect of Celecoxib on Markers of Vascular InflammationHypertension and Coronary Artery DiseaseNCT00471341University of Florida75
终止
2 期
Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung CancerHead and Neck CancerLung CancerNCT00527982M.D. Anderson Cancer Center1
Unknown
不适用
Effectiveness and Safety of Celecoxib (Celebrex 200 mg) Combined With Joins in the Treatment of Degenerative Knee Osteoarthritis: a Randomized Controlled TrialOsteoarthritisNCT04718649The Catholic University of Korea216
已完成
4 期
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (Europe)Osteoarthritis, KneeNCT00630929Pfizer's Upjohn has merged with Mylan to form Viatris Inc.388
已完成
4 期
Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)Osteoarthritis, KneeNCT00620867Pfizer's Upjohn has merged with Mylan to form Viatris Inc.393