A Feasibility Study to Examine Treatment Patterns for Secondary Stroke Prevention among Patients with Ischemic Stroke or Transient Ischemic Attack

Study type
Feasibility Study
Date of Approval
Study reference ID
FS000038
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 in order to reduce the risk of recurrent stroke. A total of 87 percent of strokes is due to blood vessel supplying clogged to the brain. Thus, it is important to understand the treatment patterns of blood clots reduction after the patients were hospitalized for stroke due to clots. Using information from general practices in England, we will identify blood clots reduction treatment options received for patients to prevent recurrent stroke. We will also assess chronic health conditions and demographics among patients with stroke due to clots. We will use this feasibility study to inform a future study on the safety and effectiveness of these treatments using Clinical Practice Research Datalink (CPRD) data.

Technical Summary

Using data collected in the CPRD Gold database with linkage to Hospital Episode Statistics and Office for National Statistics, the primary aim of this feasibility study is to examine medication treatment patterns for preventing recurrent stroke among patients hospitalized due to transient ischemic attack (TIA) or ischemic stroke. Treatment patterns will include medication type, persistence, discontinuation, and switching. The second aim of the study is to check the comorbidities and demographics among the patients who had TIA or ischemic stroke.
This study will include adult patients who were hospitalized for TIA or ischemic stroke during the period of 01/01/2012 to 31/12/2017(hospitalization index date).
A subgroup of patients who were newly diagnosed for TIA or ischemic stroke will be further identified. A minimum baseline period of 12 months prior to hospitalization index date is used to define new patients and calculate Charlson Comorbidity Index score.
Patients who initially received anti-platelet during or after hospitalization (within 180 days from the hospitalization discharge date) will be reported for treatment patterns. Treatment pattern for anti-platelet such as Aspirin, Clopidogrel, Dipyramide etc. will be stratified by type of therapy (monotherapy and combination therapy) as well as duration time from the hospitalization date to the date when first anti-platelet prescription was received by each therapy.
Patients will be followed from the anti-platelet initiation date (prescription index date) to the date of patient transfer out of the GP practice, death of the patient, or the last available data cut date. Days of supply on each therapy will be reported along with switching (patient receiving an antithrombotic prescription other than the index prescription) or discontinuation rate by each therapy.
Frequencies of all baseline covariates including age, gender, race, and comorbidities will be tabulated by category.

Health Outcomes to be Measured

The following outcomes will be examined in this feasibility study

1. Type of therapy, dosage
2. Average duration time from the hospitalization admission date to anti-platelet initial treatment by each therapy
3. Average days of supply, switch or discontinuation rate by each therapy

Collaborators

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

Linkages

HES Admitted Patient Care;ONS Death Registration Data