An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke. Non-randomized Interventional Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Incidence of Aspirin non-responders.
研究概览
简要总结
Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of CV risk. We hypothesize that EC formulation based on the previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed ischemic stroke who are just about to start aspirin.
- •No prior history of cardiovascular morbidity (including ischemic heart disease, chronic kidney disease, peripheral vascular disease) 3-18- 75 years.
- •4-Patients with ischemic stroke who underwent reperfusion intervention (catheter-directed thrombolysis and/or thrombectomy) regardless of the time of presentation (i.e within or outside the therapeutic window as the managing stroke deem fit.
排除标准
- •Concomitant antiplatelet therapy (irrespective of the duration of the treatment).
- •Patients on any prostaglandins related medications (non-steroidal anti-inflammatory drugs, misoprostol, and other ant secretory drugs among others).
- •Any salicylate-containing supplements.
- •Patients on the NG tube will be excluded from the study
研究组 & 干预措施
Enteric coated Aspirin
EC aspirin loading dose 300mg followed by 100 mg (2 days).
The study's total duration is 3 days.
干预措施: Enteric Coated Aspirin Tablet (Drug)
Plain Aspirin
Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days)
The study's total duration is 3 days.
干预措施: Plain Aspirin (Drug)
结局指标
主要结局
Incidence of Aspirin non-responders.
时间窗: At "Day 3"
Aspirin nonresponsiveness is defined as a level of residual serum TXB2 associated with elevated thrombotic risk (\<99.0% inhibition or TXB2 \>3.1 ng/ml) after 3 daily aspirin doses
次要结局
- Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.(After three daily aspirin doses ( at "Day 3"))