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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 21, 2008
Last Update Posted: October 31, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin

Cardiovascular Disease

Study Type: Observational
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 ]

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 ]

Enrollment: 1836
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681759

United States, Tennessee
Research Site
Brentwood, Tennessee, United States
Canada, Quebec
Research Site
St. Laurent, Quebec, Canada
Research Site
Paris, France
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tore Lind, MD, Medical Science Director, Nexium, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00681759     History of Changes
Other Study ID Numbers: D961FC00004
First Submitted: May 20, 2008
First Posted: May 21, 2008
Last Update Posted: October 31, 2008
Last Verified: October 2008

Keywords provided by AstraZeneca:
Low Dose Aspirin (LDA)
Cardiovascular disease
Low Dose Aspirin (LDA) use in in subjects with cardiovascular risk or disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors