A Prospective Descriptive, Multi-National, Multi-Centre Observational Study of Burden of Upper GI-Symptoms in Subjects With Cardiovascular Risk or Disease Receiving Treatment With Low-Dose Aspirin

AstraZeneca1 个研究点分布在 1 个国家目标入组 1,836 人开始时间: 2008年1月最近更新: 2008年10月31日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: AstraZeneca
入组人数: 1,836
试验地点: 1
主要终点: Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin

研究设计

研究类型: Observational
时间视角: Prospective

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

•Provision of signed written inform consent.
•Physician prescribed or recommended daily intake of Low Dose Aspirin (LDA) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months.
•Established cardiovascular disease, such as CAD (CoronaryArtery Disease), previous TIA (Transient Ischemic Attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events

排除标准

•Need for concomitant treatment with a non-ASA NSAID (Nonsteroidal Antiinflammatory Drugs) including acyclooxygenase-2 (COX-2) selective NSAID. Occasional use of up to 1 day/week is allowed.

结局指标

主要结局

Cross-sectional survey, SitePro Survey Domains including; background, UGI screening, PPI and H2 blocker usage, interaction between UGI and LDA ,UGI symptoms, HADS, Morisky Medication Taking Behavior Scale, SF12, SSA-P

时间窗: Once at enrollment

次要结局

EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization(Four times daily for three months)

研究者

发起方

AstraZeneca

申办方类型

Industry

研究点 (1)

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