An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients

• ClinicalTrials.gov Identifier: NCT00681759
• Recruitment Status: Completed
• First Posted: May 21, 2008
• Last Update Posted: October 31, 2008
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Tracking Information

• First Submitted Date: May 20, 2008
• First Posted Date: May 21, 2008
• Last Update Posted Date: October 31, 2008
• Study Start Date: January 2008
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (submitted: May 20, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT00681759 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: May 20, 2008): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
• 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
• 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 Provided
• Study Type: Observational
• Study Design: Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients with cardiovascular risk or disease receiving LDA treatment in specialist and primary care clinics.
• Condition: Cardiovascular Disease
• Intervention: Not Provided

Study Groups/Cohorts

• 1
  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).
• 2
  420 subjects stratified into three groups varying on length of time using Low Dose Aspirin (LDA)
• 3
  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.

Publications *

• Bytzer P, Pratt S, Elkin E, Næsdal J, Sörstadius E. Burden of upper gastrointestinal symptoms in patients receiving low-dose acetylsalicylic acid for cardiovascular risk management: a prospective observational study. Am J Cardiovasc Drugs. 2013 Feb;13(1):27-35. doi: 10.1007/s40256-012-0001-4.
• Pratt S, Thompson VJ, Elkin EP, Næsdal J, Sörstadius E. The impact of upper gastrointestinal symptoms on nonadherence to, and discontinuation of, low-dose acetylsalicylic acid in patients with cardiovascular risk. Am J Cardiovasc Drugs. 2010;10(5):281-8. doi: 10.2165/11584410-000000000-00000.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 30, 2008): 1836
• Original Estimated Enrollment (submitted: May 20, 2008): 2000
• Actual Study Completion Date: September 2008
• Primary Completion Date: Not Provided

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, France, United States

Administrative Information

• NCT Number: NCT00681759
• Other Study ID Numbers: D961FC00004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tore Lind, MD, Medical Science Director, Nexium, AstraZeneca Pharmaceuticals
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: AstraZeneca
• Verification Date: October 2008