Stroke is one of the leading causes of death and long-term disability. The risk of stroke is increased in patients with a prior history of stroke, therefore treatment to prevent recurrent stroke events is used for early management of stroke patients. Patients of ischemic stroke (the stroke subtype caused by blood clotting in the brain vessels) receive different treatment to reduce blood clotting according to other existing medical conditions, the actual use of these treatments in routine clinical practice remains unclear. The proposed study will describe the characteristics of the patients who were diagnosed with ischemic stroke and had no history of atrial fibrillation (a condition of irregular heart beat that leads to blood clotting in the heart and subsequent stroke), examine what treatment to reduce clotting of blood that these patients received , and calculate how soon another stroke event occurred in these patients after their first stroke. The study will use observational data that have already been collected from the UK clinical practice during a 10-year period from January 1, 2009 to December 31, 2018. Patients to be included in the study are those who were diagnosed with ischemic stroke, had no history of atrial fibrillation, and had continuous observation from at least 1 year before the diagnosis of stroke to 30 days after the diagnosis. The study results will inform the current clinical practice and outcome in ischemic stroke patients and demonstrate the needs and potential opportunities of future studies for improved care.
Stroke, with majority presented as ischemic strokes, is one of the leading causes of death and long-term disability worldwide. Anticoagulants are indicated for the prevention of acute ischemic stroke (AIS) in patients with atrial fibrillation (AF). For AIS patients without AF, antiplatelets, but not anticoagulants, are recommended for the treatment and prevention of recurrent events. However, the actual use of these antithrombotic treatment for AIS patients without AF in clinical practice has not been well-characterized. The proposed study is a real-world study to examine the pattern of antiplatelet and anticoagulation treatment and outcome of recurrent stroke in patients with AIS and no prior history of AF using the Clinical Practice Research Datalink in the UK. The proposed study will include population characterization, treatment pathway analysis, and incidence rate calculation using a retrospective cohort study design. The study population are adult patients aged ?18 years who were diagnosed with AIS, had no history of AF, and had continuous observation no less than 1 year before the diagnosis of AIS (i.e., index date) as well as longer than 30 days after the index date. The study period is a 10-year period from January 1, 2009 to December 31, 2018. The exposure of interest are treatment of Non-vitamin K antagonist oral anticoagulants (NOACs), warfarin, P2Y12 inhibitors, and individual or combination agents that include aspirin. The outcome of interest is recurrent event of ischemic stroke. Statistical analyses include descriptive statistics for baseline demographics, comorbid conditions, procedures, and medication use of patients prior to the index date, percentage of various antiplatelet and anticoagulation treatment and treatment pathway on and within 30 days after the index date, average of continuous antithrombotic treatment duration, and the incidence of recurrent ischemic stroke event within 1 year after the index date and also during the entire observation.
For the incidence rate analysis, the outcome of interest is recurrent event of ischemic stroke.
Lu Wang - Chief Investigator - Janssen Research & Development LLC
Lu Wang - Corresponding Applicant - Janssen Research & Development LLC
Elliot Barnathan - Collaborator - Janssen US
Gary Peters - Collaborator - Janssen US
James Weaver - Collaborator - Janssen Research & Development LLC
Jill Hardin - Collaborator - Janssen Research & Development LLC
JoAnne Foody - Collaborator - Janssen US
Patrick Ryan - Collaborator - Janssen Research & Development LLC
Zhong Yuan - Collaborator - Janssen Research & Development LLC
HES Admitted Patient Care