Nonfatal Myocardial InfarctionNCT01360047
Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death
An observational study of Nonfatal Myocardial Infarction and Coronary Death, run by AstraZeneca at 1 site in Spain.
Trial summary
The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time users of low dose ASA for secondary prevention… Read more about this study
- Who is it for?
- Ages 50 to 84 years
- Conditions the study is for
- Nonfatal Myocardial Infarction, Coronary Death
- How many people
- 39,513 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2011to Dec 2011
- 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: All patients aged 50 to 84 years with a first ever prescription of low-dose ASA (defined as 75-300 mg/day) for the secondary prevention of cardiovascular or cerebrovascular events (defined as any previous ischemic cerebrovascular event or ischemic heart disease) from 1 January 2000 to 31 December 2007.
Who may be able to join
- As above (study population description).
- All individuals aged 50-84 years with at least two year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study.
Who cannot join
- Recorded diagnosis of cancer prior to study start.
- Alcohol abuse or alcohol-related disease prior to study start.
- Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording) which for some individuals will be close to 8 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death - Nested Case Control Analyses in a Cohort of First-time Users of Low Dose ASA for Secondary Prevention of Cerebrovascular and Cardiovascular Outcomes.
The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time users of low dose ASA for secondary prevention using a UK primary care database.
Read the detailed description
Number of Anticipated Subjects: In case-control analysis 5.000-10.000
- Conditions
- Nonfatal Myocardial Infarction, Coronary Death
- Keywords
- MI, low dose aspirin, PPI, epidemiology
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 |
|---|---|---|
| Cases | Cases with nonfatal MI or coronary death | |
| Controls | Age, sex, and calendar-year matched controls sampled from the original study cohort to be a round number of at least four times the number of cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nonfatal MI or coronary death
Measured: Up to eight years from entry into study cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonfatal Myocardial InfarctionStudies 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
- 39,513 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis A Garcia Rodriguez, Principal investigator, CEIFE (Centro Español de Investigación Farmacoepidemiológica)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360047
- Sponsor's protocol ID
- D961FN00006
- Status last verified
- Nov 2012
- First submitted
- 24 May 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death - Nested Case Control Analyses in a Cohort of First-time Users of Low Dose ASA for Secondary Prevention of Cerebrovascular and Cardiovascular Outcomes.
- ClinicalTrials.gov ID
- NCT01360047
- Acronym / sponsor ID
- D961FN00006
- Conditions
- Nonfatal Myocardial Infarction, Coronary Death
- Keywords
- MI, low dose aspirin, PPI, epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,513 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 2011 (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 estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time users of low dose ASA for secondary prevention using a UK primary care database.
Detailed description
Number of Anticipated Subjects: In case-control analysis 5.000-10.000
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Cases with nonfatal MI or coronary death |
| Controls | – | –Age, sex, and calendar-year matched controls sampled from the original study cohort to be a round number of at least four times the number of cases |
Who may qualify
- Ages
- 50 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 50 to 84 years with a first ever prescription of low-dose ASA (defined as 75-300 mg/day) for the secondary prevention of cardiovascular or cerebrovascular events (defined as any previous ischemic cerebrovascular event or ischemic heart disease) from 1 January 2000 to 31 December 2007.
Key inclusion criteria (2 listed)
- As above (study population description).
- All individuals aged 50-84 years with at least two year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study.
Key exclusion criteria (3 listed)
- Recorded diagnosis of cancer prior to study start.
- Alcohol abuse or alcohol-related disease prior to study start.
- Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording) which for some individuals will be close to 8 years.
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
Nonfatal MI or coronary death
Time frame: Up to eight years from entry into study cohort
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 14 Nov 2012.
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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 principal investigator
CEIFE (Centro Español de Investigación Farmacoepidemiológica)
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 Nonfatal Myocardial Infarction and Coronary Death, 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 2 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 14 Nov 2012. 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?
Nonfatal MI or coronary death (time frame: Up to eight years from entry into study cohort). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2012.