NCT02311088终止2 期
Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor - A Double-blinded, Placebo-controlled, Randomized, Multicenter, Development Phase II Study
Uppsala University9 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 9
- 主要终点
- Visual analog scale area under the curve (VAS-AUC) for dyspnea
研究概览
简要总结
Ticagrelor treatment is associated with increased rates of dyspnea, where previous studies have implied a possible role of adenosine. The purpose of this study is to determine if the caffeine-antagonist is effective in reducing dyspnea related to ticagrelor.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years
- •Recent acute coronary syndrome with ongoing ticagrelor treatment
- •Stabilized clinical condition with no plans of additional revascularization
- •Dyspnea with onset after start of ticagrelor treatment
- •Willingness to abstain from caffeine intake (e.g. coffee, tea, cola-type beverages; other foods, nutritional supplements or medications containing caffeine) for the duration of the study
- •Provision of signed informed consent form
排除标准
- •Chronic obstructive pulmonary disease, asthma or other known pulmonary disease requiring daily medical therapy
- •Obstructive sleep apnea syndrome requiring therapy
- •Ongoing signs and symptoms of heart failure*, or evidence of moderately to severely reduced left ventricular (LV) function
- •Renal failure, glomerular filtration rate (GFR) <30 or on dialysis
- •Pregnancy or lactation
- •Known allergy to ticagrelor, or caffeine, or known intolerance of caffeine
- •Ongoing treatment with any of the following: quinolone antibiotics, fluvoxamine, phenylpropanolamine, carbamazepine, clozapine, lithium, non-steroidal anti-inflammatory drugs (NSAIDs); or any drug containing theophylline or caffeine.
- •Any condition that seriously increases the risk of non-compliance or loss of follow-up
研究组 & 干预措施
Caffeine
Experimental
Caffeine capsules. 200 mg twice daily orally for 7-10 days.
干预措施: Caffeine (Drug)
Placebo
Placebo Comparator
Matching placebo capsules twice daily orally for 7-10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analog scale area under the curve (VAS-AUC) for dyspnea
时间窗: 7-10 days
次要结局
- Change in dyspnea by 7-point Likert scale(7-10 days)
- High on-treatment platelet reactivity by VerifyNow(7-10 days)
研究者
研究点 (9)
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