An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
This study has been completed.
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First received: May 20, 2008
Last updated: October 30, 2008
Last verified: October 2008
The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin
|Study Design:||Time Perspective: Prospective|
|Official Title:||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|
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 [ Time Frame: Once at enrollment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization [ Time Frame: Four times daily for three months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||September 2008|
Patients who have been prescribed Low Dose Aspirin (LDA) usage in the past 12 months, or those about to begin LDA, will complete a one-time in-office survey using an electronic personal digital assistant (PDA) device (termed SitePro).
420 subjects stratified into three groups varying on length of time using Low Dose Aspirin (LDA)
Up to 20 subjects from the three EMA groups will be interviewed to further debrief their experience with Low Dose Aspirin (LDA) and upper GI symptoms.
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