An Observational, Register-based Study on Ticagrelor 60 mg Persistence and Event Rates in Clinical Practice in the US and Europe.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 7,035
- 试验地点
- 1
- 主要终点
- Treatment persistence
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 130 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Treatment persistence
时间窗: 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
时间窗: 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.
次要结局
- Incidence of Bleeding events(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(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)