Patient Characteristics, Persistence to Treatment and Outcome Events in Patients Treated With Ticagrelor 60 mg After Myocardial Infarction in Real-world Clinical Practice

Myocardial Infarction (MI) Clinical Trial

— ALETHEIA  

Official title:

An Observational, Register-based Study on Ticagrelor 60 mg Persistence and Event Rates in Clinical Practice in the US and Europe.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04568083
• Other study ID #: D5130R00057
• Status: Completed
• Start date: September 25, 2020
• Est. completion date: June 28, 2021

Study information

• Verified date: April 2022
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7035
• Est. completion date: June 28, 2021
• Est. primary completion date: June 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 130 Years

Eligibility

Inclusion Criteria:

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

• 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

Exclusion Criteria:

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

• 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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction (MI)

Locations

Country	Name	City	State
Germany	Research Site	Wismar
Italy	Research Site	Rome
Sweden	Research Site	Stockholm
United Kingdom	Research Site	London
United States	Research Site	Bethesda	Maryland
United States	Research Site	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Dyspnoea	Dyspnoea is assessed as dyspnoea diagnosed in any setting, as well as dyspnoea requiring hospitalisation, where data availability allows.	From initiation of ticagrelor 60 mg until the date of a dyspnoea event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Other	Incidence of Amputation (lower-limb)	Amputation (lower-limb) is defined as hospitalisation with a procedure code for amputation of lower limb.	From initiation of ticagrelor 60 mg until the date of amputation of lower limb, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months
Primary	Treatment persistence	Treatment discontinuation is defined on the basis of calculated days of supply from prescription data.	From initiation of ticagrelor 60 mg to discontinuation, switch or death, assessed throughout the study period up to a maximum of 36 months
Primary	Incidence of Major bleeding	Major bleeding is defined as bleeding requiring hospitalisation.	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	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)	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
Secondary	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	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

External Links

•   CSR Synopsis