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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00681759

Purpose

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

Condition
Cardiovascular Disease

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	1836
Study Start Date:	January 2008
Study Completion Date:	September 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with cardiovascular risk or disease receiving LDA treatment in specialist and primary care clinics.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681759

Locations

United States, Tennessee
Research Site
BRENTWOOD, Tennessee, United States
Canada, Quebec
Research Site
St. Laurent, Quebec, Canada
France
Research Site
PARIS, France

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Tore Lind, MD, Medical Science Director, Nexium )
Study ID Numbers:	D961FC00004
Study First Received:	May 20, 2008
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00681759 History of Changes
Health Authority:	Canada: Health Canada; France: National Consultative Ethics Committee for Health and Life Sciences; United States: Institutional Review Board

Keywords provided by AstraZeneca:

Low Dose Aspirin (LDA)
Cardiovascular disease
Low Dose Aspirin (LDA) use in in subjects with cardiovascular risk or disease

Study placed in the following topic categories:

Aspirin

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 07, 2009