An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
Completed
- Conditions
- Cardiovascular Disease
- Registration Number
- NCT00681759
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1836
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Once at enrollment
- Secondary Outcome Measures
Name Time Method EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization Four times daily for three months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms link low-dose aspirin use to upper GI symptoms in cardiovascular disease patients?
How does low-dose aspirin compare to other antiplatelet agents in managing GI symptoms among cardiovascular risk patients?
Are there specific biomarkers that predict upper GI symptom severity in patients on low-dose aspirin for cardiovascular disease?
What are the most effective strategies for managing upper GI adverse events in patients on low-dose aspirin for cardiovascular disease?
What are the implications of NCT00681759 findings on the use of proton pump inhibitors alongside low-dose aspirin in cardiovascular disease patients?
Trial Locations
- Locations (1)
Research Site
🇫🇷Paris, France
Research Site🇫🇷Paris, France