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

Cardiovascular Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681759
• Other study ID #: D961FC00004
• Status: Completed
• Phase: N/A
• First received: May 20, 2008
• Last updated: October 30, 2008
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: October 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaFrance: National Consultative Ethics Committee for Health and Life SciencesUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1836
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Canada	Research Site	St. Laurent	Quebec
France	Research Site	Paris
United States	Research Site	Brentwood	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization		Four times daily for three months	No