Treatment Patterns, Effectiveness and Safety for Secondary Stroke Prevention among Patients with Ischemic Stroke or Transient Ischemic Attack

Study type
Protocol
Date of Approval
Study reference ID
19_240
Lay Summary

Stroke is a leading cause of illness and death worldwide. Survivors of a stroke are at high risk of another stroke. Appropriate medical therapy following a stroke is key to reduce the risk of recurrent stroke. Using information from general practices in England, we will explore blood clots reduction treatment options received for patients to prevent recurrent stroke. However, these drugs can cause internal bleeding in the stomach and other organs. Internal bleeding can lead to disability, other unwanted outcomes, and in the most severe cases, death. By using Clinical Practice Research Datalink (CPRD) data with linkage to Hospital Episode Statistics (HES) and Office for National Statistics (ONS) death registration data, we will study the treatment options as well as the safety and effectiveness of these medication treatments such as bleeding, death rate and the occurrence rate of the second stroke.

Technical Summary

The primary aim of this study is to examine medication treatment patterns (antiplatelet therapy) for second stroke prevention (SSP) among non-atrial fibrillation patients who have experienced their 1st hospitalized transient ischemic attack (TIA) or ischemic stroke (IS) event. Other objectives include: (1) comparing demographics and clinical characteristics of all patients; (2) assessing the incidence rate of stoke, TIA, myocardial infarction, bleeding and mortality post 1st hospitalized TIA or IS event. Subgroups analyses will be examined such as IS patients, TIA patients, elderly patients and by calendar year(s). An exploratory objective will be to assess the treatment pattern among patients with non-hospitalized TIA (ER visits not leading to hospitalization).

Health Outcomes to be Measured

1.      Stroke: Ischemic stroke(IS); haemorrhagic stroke(HS)
2. Myocardial Infarction:
3. Mortality : CV-related Mortality, All-cause Mortality:
4. Major bleeding events: intracranial hemorrhage (ICH); gastrointestinal (GI) bleeding; other MB
5. Major Adverse Cardiac Events (MACE)
a. Overall stroke, MI, CV-related mortality
b. Overall stroke, MI, all-cause mortality
6. TIA

Collaborators

Jenny Jiang - Chief Investigator - Bristol-Myers Squibb - USA ( BMS )
Jenny Jiang - Corresponding Applicant - Bristol-Myers Squibb - USA ( BMS )
Shrutika Dixit - Collaborator - Mu SIgma

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data