Cardiovascular PreventionNCT01888575
Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy
An observational study of Cardiovascular Prevention, run by AstraZeneca at 1 site in Spain.
Trial summary
This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are: To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding. Read more about this study
- Who is it for?
- Ages 50 to 84 years
- Conditions the study is for
- Cardiovascular Prevention
- What is being tested?
- Risk of low dose aspirin discontinuation
- How many people
- 35,604 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Jun 2013
- 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 50 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a pharmacoepidemiology study using data from The Health Improvement Network (THIN) primary care database in the UK. Patients aged 50-84 years with evidence of ischemic heart disease or cerebrovascular disease, who were new users of low-dose ASA (75-300 mg/day) and who had received at least two low-dose ASA prescriptions for the secondary prevention of cardiovascular disease or cerebrovascular disease between 2000 and 2007 were identified from THIN. .
Who may be able to join
- Patients aged 50-84 years in 2000-2007.
- Patients with first prescription of low dose ASA ( see study population description).
- Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study.
Who cannot join
- Patients aged below age 50 and 85 years and above ( see study population description).
- Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
- Incomplete data recording in THIN.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention
This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are:
To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding.
To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex.
To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.
Read the detailed description
Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention
- Conditions
- Cardiovascular Prevention
- Being tested
- Risk of low dose aspirin discontinuation
- Keywords
- Discontinuation of low dose ASA,, Secondary cardiovascular prevention,, Acid-suppressing drugs,, Gastrointestinal risk,, Epidemiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk of low dose aspirin discontinuationDrug
PPI continuous use; No PPI usePPI
| Study group | Role | What they receive |
|---|---|---|
| Aspirin discontinuers; Aspirin non-discontinuers | Patients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin Receives: Drug: Risk of low dose aspirin discontinuation | |
| Drug | PPI continuous use; No PPI use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use
Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.
Measured: Up to 1 year.
Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)
Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionJun 2013
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 PreventionStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 35,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis A Garcia Rodriguez, MD, Principal investigator, CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888575
- Sponsor's protocol ID
- D5040N00008
- Status last verified
- May 2014
- First submitted
- 18 Mar 2013
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cea Soriano L, Rodriguez LA. Risk of Upper Gastrointestinal Bleeding in a Cohort of New Users of Low-Dose ASA for Secondary Prevention of Cardiovascular Outcomes. Front Pharmacol. 2010 Oct 14;1:126. doi: 10.3389/fphar.2010.00126. eCollection 2010.
PubMed 21811460Garcia Rodriguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011 Feb 22;76(8):740-6. doi: 10.1212/WNL.0b013e31820d62b5. Epub 2011 Jan 26.
PubMed 21270415
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Low-dose ASA Discontinuation Risk Associated With Concomitant PPI Use During the First Year of ASA Therapy for Secondary Prevention
- ClinicalTrials.gov ID
- NCT01888575
- Acronym / sponsor ID
- D5040N00008
- Conditions
- Cardiovascular Prevention
- Keywords
- Discontinuation of low dose ASA,, Secondary cardiovascular prevention,, Acid-suppressing drugs,, Gastrointestinal risk,, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,604 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Jun 2013 (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.
This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained .The aims of the post hoc analyses are:
To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use versus non-use, crude and adjusted by confounding.
To estimate the one year risk of discontinuation of use of low-dose ASA associated to PPI concomitant use stratified by age and sex.
To evaluate other predictors of discontinuation of low-dose ASA during the first year of ASA therapy.
Detailed description
Assessment of low-dose ASA discontinuation risk associated with concomitant PPI use during the first year of ASA therapy for secondary prevention
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin discontinuers; Aspirin non-discontinuers | – | Drug: Risk of low dose aspirin discontinuationPatients on low dose ASA for secondary prevention that discontinue aspirin and those not discontinuing aspirin |
| Drug | – | –PPI continuous use; No PPI use |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a pharmacoepidemiology study using data from The Health Improvement Network (THIN) primary care database in the UK. Patients aged 50-84 years with evidence of ischemic heart disease or cerebrovascular disease, who were new users of low-dose ASA (75-300 mg/day) and who had received at least two low-dose ASA prescriptions for the secondary prevention of cardiovascular disease or cerebrovascular disease between 2000 and 2007 were identified from THIN. .
Key inclusion criteria (3 listed)
- Patients aged 50-84 years in 2000-2007.
- Patients with first prescription of low dose ASA ( see study population description).
- Patients were required to have been enrolled with their primary care practitioner (PCP) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study.
Key exclusion criteria (3 listed)
- Patients aged below age 50 and 85 years and above ( see study population description).
- Patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease.
- Incomplete data recording in THIN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk of low dose aspirin discontinuationPPI continuous use; No PPI usePPI | Drug | Aspirin discontinuers; Aspirin non-discontinuers |
Primary outcome
Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use
Time frame: Up to 1 year.
Risk (hazard ratios) of low dose ASA discontinuation associated with continuous PPI use vs. non-use.
Risk of low dose ASA discontinuation associated with baseline gastrointestinal risk category ( high risk versus low risk)
Time frame: Up to 1 year
Risk ( hazard ratios) of low dose ASA discontinuation associated with baseline gastrointestinal risk category( high risk versus low risk).
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 13 May 2014.
- Background: PubMed 21811460Cea Soriano L, Rodriguez LA. Risk of Upper Gastrointestinal Bleeding in a Cohort of New Users of Low-Dose ASA for Secondary Prevention of Cardiovascular Outcomes. Front Pharmacol. 2010 Oct 14;1:126. doi: 10.3389/fphar.2010.00126. eCollection 2010.
- Background: PubMed 21270415Garcia Rodriguez LA, Cea Soriano L, Hill C, Johansson S. Increased risk of stroke after discontinuation of acetylsalicylic acid: a UK primary care study. Neurology. 2011 Feb 22;76(8):740-6. doi: 10.1212/WNL.0b013e31820d62b5. Epub 2011 Jan 26.
- D5040N00008\_CSP.pdfLink provided by the sponsor.
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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.
Luis A Garcia Rodriguez, MD principal investigator
CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Prevention, run by AstraZeneca at 1 site in Spain.
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 3 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 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Risk of low dose ASA discontinuation associated with continuous PPI use vs.non-use (time frame: Up to 1 year.). The study lists 2 primary outcomes in all. 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 NCT01888575, 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 13 May 2014.