Effectiveness of the Timing of the Administration of Aspirin in Hypertensive Patients Treated With Low Doses of Acetyl Salicylic Acid for Secondary Prevention - TAHPS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period
研究概览
简要总结
The goal is to investigate in patients with high blood pressure, BP, namely, those with systolic blood pressure and diastolic blood pressure, SBP/DBP higher than or equal to 140/90 mmHg, and high cardiovascular risk, under treatment with low-dose acetylsalicylic acid, ASA, whether changing the time they take the drug (same dose) to bedtime (from taking it at some point during the active part of the day) produces a drop in their blood pressure (mean systolic and diastolic over 24 hours) of at least 2.5 mm Hg; and also whether among non-dippers, under secondary treatment with low-dose ASA, there is be a greater decrease in their night BP when the drug is taken in the evening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertensive patients (≥140/90)
- •Patients from 18 to 80 years old
- •Patients are currently taking low doses of ASA during the day, for secondary prevention of cardiovascular events
- •Patients have been stable for at least one month with their current antihypertensive and antiplatelet therapy.
排除标准
- •Severe and/or terminal illness
- •Moderate/severe congestive heart failure (CHF), New York Heart Association, NYHA stage ≥ III
- •Moderate/severe chronic renal failure glomerular filtration rate <45ml/min.
- •Physical or mental illness that prevents the patient´s collaboration
- •Being a heavy drinker, consuming more than 280 g of alcohol per week in the case of men or 170 g for women31
- •Concomitant treatment with other antiplatelets or anticoagulants
- •Taking nonsteroidal antiinflammatory drugs, NSAIDs, on a regular basis
- •Treatment with ASA at doses outside those established in the inclusion criteria (above)
- •ASA already being taken in the evening
- •Being a shift worker or having a very intensive work schedule
- •Hospital admission during the clinical trial
- •Changes being made in the antihypertensive and antiplatelet therapy taken by the patient during the seven months of the trial
- •Patients with unstable treatment or clinical condition requiring frequent adjustments thereof.
- •Compliance with less than 90% of the doses, both those for daytime and those for evening administration
研究组 & 干预措施
ASA evening&placebo morning
Patients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning.
干预措施: ASA evening (Drug)
ASA evening&placebo morning
Patients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning.
干预措施: Placebos morning (Drug)
ASA morning&placebo evening
Patients will receive acetylsalicylic acid (100 mg) in the morning and placebo in the evening
干预措施: Acetylsalicylic morning (Drug)
ASA morning&placebo evening
Patients will receive acetylsalicylic acid (100 mg) in the morning and placebo in the evening
干预措施: Placebo evening (Drug)
结局指标
主要结局
Mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period
时间窗: Change from baseline in sistolyc blood pressure at five months
To evaluate the effect of evening administration of low doses of aspirin (100 mg) on the BP of hypertensive patients with high cardiovascular risk, comparing with the effect of day administration, we are going to measure the change in the mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period from baseline at the end of the study, five months later.
次要结局
- Mean of day/night SBP and DBP ratios measured with Ambulatory Blood Pressure monitoring Monitoring(Change from baseline in sistolyc blood pressure at five months)
- Percentage of adverse events related to ASA evening administration versus day administration(Change from baseline in sistolyc blood pressure at five months)
- The mean of heart rate (HR) and the mean of pulse pressure (PP)(Change from baseline in sistolyc blood pressure at five months)
研究者
Victoria Ruiz Arzalluz
Primary Care Practitioner in Basque Health Service
Basque Health Service