Myocardial Infarction (MI)ALETHEIANCT04568083
Patient Characteristics, Persistence to Treatment and Outcome Events in Patients Treated With Ticagrelor 60 mg After Myocardial Infarction in Real-world Clinical Practice
An observational study of Myocardial Infarction (MI), run by AstraZeneca at 6 sites in 5 countries.
Trial summary
This is an observational study based on secondary data extracted from multiple register-based data sources in the US and Europe (Sweden, United Kingdom, Italy, Germany). The study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction in real-world clinical practice, and… Read more about this study
- Who is it for?
- Ages Up to 130 years
- Conditions the study is for
- Myocardial Infarction (MI)
- How many people
- 7,035 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 25 Sep 2020to 28 Jun 2021
- 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 Up to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will include patients who are hospitalised with a primary diagnosis of MI, identified using diagnostic codes, divided into cohorts receiving and not receiving treatment with ticagrelor 60 mg. Co-prescription of aspirin will also be identified where available.
Who may be able to join
- Primary Analysis Population:
- Hospitalisation with a primary diagnosis of MI during the eligibility period
- Ticagrelor cohort: A first prescription of ticagrelor 60 mg after the most recent hospitalisation with a primary diagnosis of MI.
- Non-ticagrelor cohort: A prescription of clopidogrel, prasugrel or ticlopidine, or no prescription for any of these medications, at a comparable timepoint relative to their MI as for the ticagrelor cohort
- Secondary Analysis Population:
- The qualifying prescription 12-36 months after a hospitalisation with a primary diagnosis of MI and treatment with an ADP receptor antagonist (clopidogrel, prasugrel, ticagrelor 90 mg, ticlopidine) ≤12 months prior to the qualifying prescription, or the qualifying prescription 12-24 months after a hospitalisation with a primary diagnosis of MI AND
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- Age ≥50 years
- At least one of the following risk factors:
- Age ≥ 65 years
- Diabetes mellitus requiring medication
- A second prior MI
- Evidence of multivessel coronary artery disease
- Chronic non-end-stage renal dysfunction
Who cannot join
- Applicable to the Primary and Seconday Analysis Populations:
- Dies, emigrates, or disenrolls from the database (where applicable) prior to the ticagrelor approval date.
- Ineligibility for ticagrelor use (restricted to the conditions possible to capture within the data sources)-one or more of the following:
- Concomitant use of an anticoagulant
- Prior ischaemic stroke
- Prior history of intracranial bleeding
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- Severe hepatic impairment
- Gastrointestinal bleeding
- Renal failure requiring dialysis
- Concomitant use of a strong CYP3A4 inhibitor or inducer
- <1 year of data available prior to the qualifying MI (for assessment of patient characteristics at qualifying MI)
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
United States2 sites
Research Site
Bethesda, Maryland, 20814
Research Site
Waltham, Massachusetts, 02451
About this study
Official title: An Observational, Register-based Study on Ticagrelor 60 mg Persistence and Event Rates in Clinical Practice in the US and Europe.
This is an observational study based on secondary data extracted from multiple register-based data sources in the US and Europe (Sweden, United Kingdom, Italy, Germany). The study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction in real-world clinical practice, and describe their patient characteristics and duration of treatment. If the a priori threshold of 5,000 person-years on treatment with ticagrelor 60 mg is met, outcome events (bleeding and cardiovascular events) will also be analysed and described.
Read the detailed description
This observational cohort study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction (MI), and describe their patient characteristics and persistence to treatment. To contextualise the characteristics of the ticagrelor patients, two reference cohorts will be created, including patients treated with another P2Y12 inhibitor than ticagrelor (clopidogrel, prasugrel, or ticlopidine), and patients not treated with any P2Y12 inhibitor, within a comparable timepoint from an MI as for the ticagrelor 60 mg patients. If the a priori threshold of 5,000 person-years on treatment with ticagrelor 60 mg is met, to ensure sufficient precision, outcome events (bleeding and cardiovascular events) will also be analysed and described. Outcome events will only be described in the ticagrelor cohorts; no comparison of outcomes will be made between the ticagrelor and the reference cohorts.
The primary outcome is bleeding requiring hospitalisation. The secondary outcomes include components of the primary outcome, and cardiovascular outcomes. Persistence to treatment with ticagrelor 60 mg will also be assessed The study will be performed in the US and 4 European countries (Sweden, United Kingdom, Italy, Germany).
- Conditions
- Myocardial Infarction (MI)
- Keywords
- Myocardial Infarction, Ticagrelor 60 mg, Antiplatelet agents, Medication persistence, Drug utilization, Bleeding, MACE, Cardiovascular, Cohort study, Observational study, Real-world evidence
- Medical subject headings
- Myocardial Infarction, Medication Adherence, Hemorrhage
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 |
|---|---|---|
| Ticagrelor cohort | Patients initiating ticagrelor 60 mg after an MI, with no prescription of ticagrelor 60 mg prior to their qualifying MI. The qualifying MI is defined as the most recent MI occurring before the first ticagrelor 60 mg prescription. | |
| Non-ticagrelor cohort | Patients not prescribed ticagrelor 60 mg at a comparable time point after an MI as matched patients in the ticagrelor cohort. Patients may be prescribed another P2Y12 inhibitor or aspirin alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment persistence
Treatment discontinuation is defined on the basis of calculated days of supply from prescription data.
Measured: From initiation of ticagrelor 60 mg to discontinuation, switch or death, assessed throughout the study period up to a maximum of 36 months
Incidence of Major bleeding
Major bleeding is defined as bleeding requiring hospitalisation.
Measured: From initiation of ticagrelor 60 mg until the date of a major bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Secondary outcomes (2)
Incidence of Bleeding events
- Intracranial haemorrhage
- Gastrointestinal bleeding requiring hospitalisation
- Bleeding other than intracranial haemorrhage or gastrointestinal bleeding requiring hospitalisation
- Fatal bleeding
- Bleeding not requiring hospitalisation (managed in outpatient care/emergency care not requiring hospitalisation)
Measured: From initiation of ticagrelor 60 mg until the date of a bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Incidence of Cardiovascular (CV) events
- Composite of hospitalisation for MI or stroke, and all-cause mortality
- Composite of hospitalisation for MI or stroke, and CV death (three-point MACE)
- Hospitalisation for MI, hospitalisation for stroke, hospitalisation for ischaemic stroke, CV death, CHD death, all-cause mortality assessed individually
Measured: From initiation of ticagrelor 60 mg until the date of a CV event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start25 Sep 2020
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial Infarction (MI)Studies 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
- 7,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568083
- Sponsor's protocol ID
- D5130R00057
- Acronym
- ALETHEIA
- Status last verified
- Apr 2022
- First submitted
- 15 Sep 2020
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Bonaca MP, Lesen E, Giannitsis E, Hedberg J, Jernberg T, Lambrelli D, Duong M, Maggioni AP, Ariza-Sole A, Ten Berg J, Storey RF. Characteristics and outcomes in patients with a prior myocardial infarction treated with extended dual antiplatelet therapy with ticagrelor 60 mg: findings from ALETHEIA, a multi-country observational study. Eur Heart J Cardiovasc Pharmacother. 2023 Dec 14;9(8):701-708. doi: 10.1093/ehjcvp/pvad062.
PubMed 37653447
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Register-based Study on Ticagrelor 60 mg Persistence and Event Rates in Clinical Practice in the US and Europe.
- ClinicalTrials.gov ID
- NCT04568083
- Acronym / sponsor ID
- ALETHEIA / D5130R00057
- Conditions
- Myocardial Infarction (MI)
- Keywords
- Myocardial Infarction, Ticagrelor 60 mg, Antiplatelet agents, Medication persistence, Drug utilization, Bleeding, MACE, Cardiovascular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,035 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 29 Sep 2020 (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.
This is an observational study based on secondary data extracted from multiple register-based data sources in the US and Europe (Sweden, United Kingdom, Italy, Germany). The study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction in real-world clinical practice, and describe their patient characteristics and duration of treatment. If the a priori threshold of 5,000 person-years on treatment with ticagrelor 60 mg is met, outcome events (bleeding and cardiovascular events) will also be analysed and described.
Detailed description
This observational cohort study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction (MI), and describe their patient characteristics and persistence to treatment. To contextualise the characteristics of the ticagrelor patients, two reference cohorts will be created, including patients treated with another P2Y12 inhibitor than ticagrelor (clopidogrel, prasugrel, or ticlopidine), and patients not treated with any P2Y12 inhibitor, within a comparable timepoint from an MI as for the ticagrelor 60 mg patients. If the a priori threshold of 5,000 person-years on treatment with ticagrelor 60 mg is met, to ensure sufficient precision, outcome events (bleeding and cardiovascular events) will also be analysed and described. Outcome events will only be described in the ticagrelor cohorts; no comparison of outcomes will be made between the ticagrelor and the reference cohorts.
The primary outcome is bleeding requiring hospitalisation. The secondary outcomes include components of the primary outcome, and cardiovascular outcomes. Persistence to treatment with ticagrelor 60 mg will also be assessed The study will be performed in the US and 4 European countries (Sweden, United Kingdom, Italy, Germany).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ticagrelor cohort | – | –Patients initiating ticagrelor 60 mg after an MI, with no prescription of ticagrelor 60 mg prior to their qualifying MI. The qualifying MI is defined as the most recent MI occurring before the first ticagrelor 60 mg prescription. |
| Non-ticagrelor cohort | – | –Patients not prescribed ticagrelor 60 mg at a comparable time point after an MI as matched patients in the ticagrelor cohort. Patients may be prescribed another P2Y12 inhibitor or aspirin alone. |
Who may qualify
- Ages
- Up to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include patients who are hospitalised with a primary diagnosis of MI, identified using diagnostic codes, divided into cohorts receiving and not receiving treatment with ticagrelor 60 mg. Co-prescription of aspirin will also be identified where available.
Key inclusion criteria (13 listed)
- Hospitalisation with a primary diagnosis of MI during the eligibility period
- Ticagrelor cohort: A first prescription of ticagrelor 60 mg after the most recent hospitalisation with a primary diagnosis of MI.
- Non-ticagrelor cohort: A prescription of clopidogrel, prasugrel or ticlopidine, or no prescription for any of these medications, at a comparable timepoint relative to their MI as for the ticagrelor cohort
- The qualifying prescription 12-36 months after a hospitalisation with a primary diagnosis of MI and treatment with an ADP receptor antagonist (clopidogrel, prasugrel, ticagrelor 90 mg, ticlopidine) ≤12 months prior to the qualifying prescription, or the qualifying prescription 12-24 months after a hospitalisation with a primary diagnosis of MI AND
- Age ≥50 years
Key exclusion criteria (11 listed)
- Dies, emigrates, or disenrolls from the database (where applicable) prior to the ticagrelor approval date.
- Ineligibility for ticagrelor use (restricted to the conditions possible to capture within the data sources)-one or more of the following:
- <1 year of data available prior to the qualifying MI (for assessment of patient characteristics at qualifying MI)
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
Treatment persistence
Time frame: From initiation of ticagrelor 60 mg to discontinuation, switch or death, assessed throughout the study period up to a maximum of 36 months
Treatment discontinuation is defined on the basis of calculated days of supply from prescription data.
Incidence of Major bleeding
Time frame: From initiation of ticagrelor 60 mg until the date of a major bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Major bleeding is defined as bleeding requiring hospitalisation.
2 secondary outcomes
Incidence of Bleeding events
Time frame: From initiation of ticagrelor 60 mg until the date of a bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Incidence of Cardiovascular (CV) events
Time frame: From initiation of ticagrelor 60 mg until the date of a CV event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 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 13 Apr 2022.
- Derived from this study: PubMed 37653447Bonaca MP, Lesen E, Giannitsis E, Hedberg J, Jernberg T, Lambrelli D, Duong M, Maggioni AP, Ariza-Sole A, Ten Berg J, Storey RF. Characteristics and outcomes in patients with a prior myocardial infarction treated with extended dual antiplatelet therapy with ticagrelor 60 mg: findings from ALETHEIA, a multi-country observational study. Eur Heart J Cardiovasc Pharmacother. 2023 Dec 14;9(8):701-708. doi: 10.1093/ehjcvp/pvad062.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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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.
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction (MI), run by AstraZeneca at 6 sites in 5 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 13 inclusion and 11 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Italy, Sweden, United Kingdom. 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?
Treatment persistence (time frame: From initiation of ticagrelor 60 mg to discontinuation, switch or death, assessed throughout the study period up to a maximum of 36 months). 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 NCT04568083, which also lists 1 linked publication.
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 Apr 2022.