NCT04099238

Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care

Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,739 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 20 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial fibrillation) in a UK general population using The Health Improvement Network (THIN) database. The main aim of the study is to estimate in how many patients atrial fibrillation was diagnosed at the moment of stroke and to describe whether these patients received OAC at the time of the stroke. In addition, researchers want to learn about the relative risk of ischemic stroke when such patients did not continue OAC treatment.

Detailed description

The primary objectives of the study are to determine the incidence of ischemic stroke in patients registered in the British primary care THIN database and to investigate the OAC exposure, OAC treatment patterns and the relative risk of having an ischemic stroke in relation to OAC treatment for a subgroup of patients, who were diagnosed with non-valvular atrial fibrillation (NVAF) prior to ischemic stroke. Secondary objectives are to determine the number of patients having NVAF diagnosed at the time of ischemic stroke and within 1 and 12 months after ischemic stroke; to describe cardiovascular risk factors for ischemic stroke and pharmacological treatments before and 12 months after ischemic stroke, and to estimate the case-fatality at 1 and 12 months after the occurrence of ischemic stroke.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Oral anticoagulant	Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-07-16
• Completion: 2020-07-16
• First posted: 2019-09-23
• Last updated: 2021-04-26

Locations

1 site across 1 country: United Kingdom