NCT02550717

Epidemiological Study on the Safety of Aspirin in The Health Improvement Network (THIN)

A Pharmacoepidemiological Study on the Risk of Bleeding in New Users of Low-dose Aspirin (ASA) in The Health Improvement Network (THIN), UK

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 398,158 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 40 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

To investigate the risk of major bleeding (including gastrointestinal and intracranial bleeding episodes) among new users of low-dose acetylsalicylic acid (ASA) in clinical practice

Detailed description

These will be based on population-based cohorts using data from a primary care database in the UK: The Health Improvement Network (THIN) and will serve to make a clinically meaningful benefit-risk assessment regarding major bleeding consequences of ASA exposure in general population.

Conditions

• Secondary Prevention
• Stroke
• Ischemic Heart Disease
• Coronary Heart Disease

Interventions

Type	Name	Description
DRUG	Acetylsalicylic Acid (Aspirin, BAYE4465)	Low-dose ASA for secondary prevention of cardiovascular events
DRUG	Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs	Secondary prevention of cardiovascular events

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-31
• Completion: 2017-03-31
• First posted: 2015-09-15
• Last updated: 2018-10-24

Locations

1 site across 1 country: United Kingdom