Myocardial InfarctionCOMPLYNCT03661710
Adherence to Prescribed Medication: Elucidating the Gap Between Guideline Recommendation and Real Life in Myocardial Infarction
An observational study of Myocardial Infarction and Adherence, Medication, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of the study is to investigate the adherence to prescribed post-infarction medication and to cardiac rehabilitation in patients after acute myocardial infarction. In addition, their impact on cardiovascular events will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Adherence, Medication
- How many people
- 300 participants
- Where
- 1 siteAustria
- Study dates
- 30 Jan 2019to 30 Jan 2023
- 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
- Adult, Older adult
Study population: Patients after acute myocardial infarction requiring dual platelet inhibition
Who may be able to join
- Acute myocardial infarction
- Willingness to participate
Who cannot join
- Inclusion in an interventional study interfering with standard of care medication
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Andreas Kammerlander, MD PhD
About this study
The aim of the study is to investigate the adherence to prescribed post-infarction medication and to cardiac rehabilitation in patients after acute myocardial infarction. In addition, their impact on cardiovascular events will be investigated.
- Conditions
- Myocardial Infarction, Adherence, Medication
- Being tested
- Investigating Adherence to Standard of Care Medication and Cardiac Rehabilitation
- Medical subject headings
- Myocardial Infarction, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigating Adherence to Standard of Care Medication and Cardiac RehabilitationOther
Information from health care insurance providers on how many patients adhered to prescribed medication and how many underwent cardiac rehabilitation and how adherence influenced cardiovascular outcome will be retrieved
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Event
Composite of re-hospitalization due to acute MI, heart failure, stent thrombosis, fatal MI, and overall mortality
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start30 Jan 2019
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andreas Kammerlander, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661710
- Sponsor's protocol ID
- COMPLY-40400
- Acronym
- COMPLY
- Status last verified
- Aug 2019
- First submitted
- 1 Sep 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Prescribed Medication: Elucidating the Gap Between Guideline Recommendation and Real Life in Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03661710
- Acronym / sponsor ID
- COMPLY / COMPLY-40400
- Conditions
- Myocardial Infarction, Adherence, Medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 7 Sep 2018 (actual)
- 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 aim of the study is to investigate the adherence to prescribed post-infarction medication and to cardiac rehabilitation in patients after acute myocardial infarction. In addition, their impact on cardiovascular events will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients after acute myocardial infarction requiring dual platelet inhibition
Key inclusion criteria (2 listed)
- Acute myocardial infarction
- Willingness to participate
Key exclusion criteria (1 listed)
- Inclusion in an interventional study interfering with standard of care medication
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 |
|---|---|---|
| Investigating Adherence to Standard of Care Medication and Cardiac RehabilitationInformation from health care insurance providers on how many patients adhered to prescribed medication and how many underwent cardiac rehabilitation and how adherence influenced cardiovascular outcome will be retrieved | Other | – |
Primary outcome
Cardiovascular Event
Time frame: 3 years
Composite of re-hospitalization due to acute MI, heart failure, stent thrombosis, fatal MI, and overall mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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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.
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 Myocardial Infarction and Adherence, Medication, run by Medical University of Vienna at 1 site in Austria.
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 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: status not confirmed, as of the sponsor's last update on 14 Aug 2019. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Kammerlander, MD PhD (+43140400 ext. 46140, andreas.kammerlander@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular Event (time frame: 3 years). 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 Aug 2019.