Cardiovascular DiseaseNCT00681759
An Observational Study of Burden of Upper GI-Symptoms in CV Risk Patients
An observational study of Cardiovascular Disease, run by AstraZeneca at 3 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 1,836 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2008to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cardiovascular risk or disease receiving LDA treatment in specialist and primary care clinics.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin
- Conditions
- Cardiovascular Disease
- Keywords
- Low Dose Aspirin (LDA), Cardiovascular disease, Low Dose Aspirin (LDA) use in in subjects with cardiovascular risk or disease
- Medical subject headings
- Cardiovascular Diseases, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once at enrollment
Secondary outcomes (1)
EMA assessments including: Sleep, Mood, Activities, Eating/food,GI symptoms,GI coping strategies, Medication usage, Healthcare Utilization
Measured: Four times daily for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJan 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,836 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681759
- Sponsor's protocol ID
- D961FC00004
- Status last verified
- Oct 2008
- First submitted
- 20 May 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Bytzer P, Pratt S, Elkin E, Naesdal J, Sorstadius 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.
PubMed 23315343Pratt S, Thompson VJ, Elkin EP, Naesdal J, Sorstadius 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.
PubMed 20666569
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00681759
- Acronym / sponsor ID
- D961FC00004
- Conditions
- Cardiovascular Disease
- Keywords
- Low Dose Aspirin (LDA), Cardiovascular disease, Low Dose Aspirin (LDA) use in in subjects with cardiovascular risk or disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,836 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Study completion
- Sep 2008 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiovascular risk or disease receiving LDA treatment in specialist and primary care clinics.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2008.
- Derived from this study: PubMed 23315343Bytzer P, Pratt S, Elkin E, Naesdal J, Sorstadius 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.
- Derived from this study: PubMed 20666569Pratt S, Thompson VJ, Elkin EP, Naesdal J, Sorstadius 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by AstraZeneca at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681759, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2008.