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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00681759
First received: May 20, 2008
Last updated: October 30, 2008
Last verified: October 2008
History of Changes
  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

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:

Drug Information available for: Aspirin
U.S. FDA Resources

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 ]

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 by AstraZeneca

Additional 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
Study First Received: May 20, 2008
Last Updated: October 30, 2008
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

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

ClinicalTrials.gov processed this record on May 19, 2013