DISCOVER: A Single-site Double-blind Placebo-controlled Randomized Mechanistic Crossover Trial to Assess the Influence of boDy weIght on aSpirin-triggered speCialized prO-resolVing mEdiatoRs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change in Serum 15R-LXA4
研究概览
简要总结
This study employs a placebo-controlled randomized cross-over design to investigate the impact of body weight and aspirin dose on levels of specialized pro-resolving lipid mediators in blood and neutrophils.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Age between 40 and 70 years
排除标准
- •Anti-platelet medication use in the past 7 days
- •Aspirin intolerance or allergy
- •Known bleeding or clotting disorder
- •Chronic inflammatory or connective tissue disease
- •Immunological deficiency
- •Diabetes mellitus
- •Prior gastric or bariatric surgery
- •Active smoking
- •Platelet count <100,000
- •Use of omega-3 fatty acid supplementation
- •Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases
- •Corticosteroid use
- •Recent initiation or change in dose of statin therapy
研究组 & 干预措施
Aspirin 81mg, Then Aspirin 325mg
After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.
干预措施: Aspirin 81mg (Drug)
Aspirin 81mg, Then Aspirin 325mg
After a 3 week placebo run-in period, participants first receive Aspirin 81mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 325mg capsule daily for another 3 weeks.
干预措施: Aspirin 325mg (Drug)
Aspirin 325mg, Then Aspirin 81mg
After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.
干预措施: Aspirin 81mg (Drug)
Aspirin 325mg, Then Aspirin 81mg
After a 3 week placebo run-in period, participants first receive Aspirin 325mg capsule daily for 3 weeks. After a placebo washout period of 3 weeks, they then receive Aspirin 81mg capsule daily for another 3 weeks.
干预措施: Aspirin 325mg (Drug)
结局指标
主要结局
Change in Serum 15R-LXA4
时间窗: Week 9, Week 12
Change in Serum 15R-LXA4
时间窗: Week 3, Week 6
次要结局
- Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)(Week 9, Week 12)
- Change in lipid mediator profile of leukotrienes(Week 9, Week 12)
- Change in lipid mediator profile of prostaglandins(Week 9, Week 12)
- Change in platelet-monocyte aggregates(Week 9, Week 12)
- Change in platelet-neutrophil aggregates(Week 9, Week 12)
- Change in platelet surface expression of CD62P(Week 9, Week 12)
- Change in leukocyte expression of ALX/FPR2(Week 9, Week 12)
- Change in leukocyte expression of GPR32(Week 9, Week 12)
- Change in leukocyte expression of ERV1/ChemR23(Week 9, Week 12)
- Change in leukocyte expression of BLT1(Week 9, Week 12)
- Change in platelet surface expression of CD62P(Week 3, Week 6)
- Change in leukocyte expression of ALX/FPR2(Week 3, Week 6)
- Change in lipid mediator profile of specialized pro-resolving mediators (SPMs)(Week 3, Week 6)
- Change in lipid mediator profile of leukotrienes(Week 3, Week 6)
- Change in lipid mediator profile of prostaglandins(Week 3, Week 6)
- Change in platelet-monocyte aggregates(Week 3, Week 6)
- Change in platelet-neutrophil aggregates(Week 3, Week 6)
- Change in leukocyte expression of GPR32(Week 3, Week 6)
- Change in leukocyte expression of ERV1/ChemR23(Week 3, Week 6)
- Change in leukocyte expression of BLT1(Week 3, Week 6)