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

Completed

Conditions studied: Myocardial Infarction (MI)

In brief

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.

Key facts

Study ID

NCT04568083

Run by

AstraZeneca

People needed

7035

Starts

2020-09-25

Expected to finish

2021-06-28

Last updated by the study team

2022-04-13

Who can join

Age: any, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Research Site — Bethesda, Maryland, United States
• Research Site — Waltham, Massachusetts, United States
• Research Site — Wismar, Germany
• Research Site — Rome, Italy
• Research Site — Stockholm, Sweden
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.