Clinical trial NCT04568083: Patient Characteristics, Persistence to Treatment and Outcome Events in Patients Treated With Ticagrelor 60 mg After Myocardial Infarction in Real-world Clinical Practice
Official title: An Observational, Register-based Study on Ticagrelor 60 mg Persistence and Event Rates in Clinical Practice in the US and Europe.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 7035
Sex: ALL
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Treatment persistence
timeFrame: From initiation of ticagrelor 60 mg to discontinuation, switch or death, assessed throughout the study period up to a maximum of 36 months
measure: Incidence of Major bleeding
timeFrame: 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:
measure: Incidence of Bleeding events
timeFrame: 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
measure: Incidence of Cardiovascular (CV) events
timeFrame: 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
Other outcomes:
measure: Incidence of Dyspnoea
timeFrame: 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
measure: Incidence of Amputation (lower-limb)
timeFrame: 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
Locations:
city: Bethesda
country: United States
facility: Research Site
state: Maryland
city: Waltham
country: United States
facility: Research Site
state: Massachusetts
city: Wismar
country: Germany
facility: Research Site
city: Rome
country: Italy
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
References: