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

NCT02550717 | Completed

• 1 other identifier: 18116
• Study Type: observational
• Target: 398,158
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Secondary Prevention; Stroke; Ischemic Heart Disease; Coronary Heart Disease

Keywords

Low-dose Acetylsalicylic Acid,; Bleeding,; The Health Improvement Network (THIN),; Cardiovascular; Secondary prevention of cardiovascular events

Outcome Measures

Primary Outcomes (9)

• Incidence of Intracranial bleeding among new users of low-dose Acetylsalicylic acid (ASA).

  Up to 13 years

• Incidence of Upper gastrointestinal bleeding among new users of low-dose ASA.

  Up to 13 years

• Incidence of Lower gastrointestinal bleeding among new users of low-dose ASA

  Up to 13 years

• Time to Intracranial bleeding among new users of low-dose ASA

  Up to 13 years

• Time to Upper gastrointestinal bleeding among new users of low-dose ASA

  Up to 13 years

• Time to Lower gastrointestinal bleeding among new users of low-dose ASA

  Up to 13 years

• Relative risk of Intracranial bleeding among new users of low dose ASA

  Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.

  Up to 13 years

• Relative risk of Upper gastrointestinal bleeding among new users of low-dose ASA

  Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.

  Up to 13 years

• Relative risk of Lower gastrointestinal bleeding among new users of low-dose ASA

  Relative risk is calculated as incident rate ratio produced by dividing the incidence rate of the outcome of interest in the exposed category by the incidence rate of the outcome of interest in the unexposed.

  Up to 13 years

Secondary Outcomes (3)

• Relative risk of Intracranial bleeding associated with use of other medications.

  Up to 13 years

• Relative risk of Upper gastrointestinal bleeding associated with use of other medications

  Up to 13 years

• Relative risk of Lower gastrointestinal bleeding associated with use of other medications.

  Up to 13 years

Study Arms (2)

Acetylsalicylic Acid

New users of low-dose Acetylsalicylic Acid (ASA)

Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)

Other medications

Users of other medications such as clopidogrel, oral anticoagulants, non-steroidal anti-inflammatory drugs (NSAIDs) and selective serotonin reuptake inhibitors (SSRIs)

Drug: Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs

Interventions

Acetylsalicylic Acid (Aspirin, BAYE4465) DRUG

Low-dose ASA for secondary prevention of cardiovascular events

Acetylsalicylic Acid

Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs DRUG

Secondary prevention of cardiovascular events

Other medications

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

THIN is a computerized medical research database that contains systematically recorded data on more than 3 million UK primary care patients. It is representative of this population with regard to age, sex, and geographic distribution, and has been validated for use in pharmacoepidemiological and epidemiological research in multiple studies 13. Participating Primary Care Physicians (PCPs) record prospectively data as part of their routine patient care, including demographics and life style factors (e.g. alcohol use, body mass index (BMI) and smoking status), consultation rates, referrals, hospital admissions, laboratory test results, diagnoses, prescriptions ordered by the PCPs, and a free text section, and send their data anonymously to THIN for use in research projects.

You may qualify if:

• Aged 40-84 years
• Enrolled with the Primary Care Physician (PCP) for at least 2 years,
• To have a history of computerized prescriptions for at least 1 year prior
• To have at least one encounter/visit recorded in the last three years

You may not qualify if:

• To be exposed to low dose ASA before entering in the study
• Having a diagnosis of cancer before entering in the study
• Having a diagnosis of alcohol abuse before entering in the study
• Having a diagnosis of coagulopathies before entering in the study
• Having a diagnosis of esophageal varices before entering in the study
• Having a diagnosis of chronic liver disease before entering in the study

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, United Kingdom

Location

Related Publications (2)

• Cea Soriano L, Gaist D, Soriano-Gabarro M, Bromley S, Garcia Rodriguez LA. Low-dose aspirin and risk of intracranial bleeds: An observational study in UK general practice. Neurology. 2017 Nov 28;89(22):2280-2287. doi: 10.1212/WNL.0000000000004694. Epub 2017 Nov 1.

  PMID: 29093065 RESULT

• Cea Soriano L, Gaist D, Soriano-Gabarro M, Garcia Rodriguez LA. Incidence of intracranial bleeds in new users of low-dose aspirin: a cohort study using The Health Improvement Network. J Thromb Haemost. 2017 Jun;15(6):1055-1064. doi: 10.1111/jth.13686. Epub 2017 May 2.

  PMID: 28371181 RESULT

MeSH Terms

Conditions

Stroke; Myocardial Ischemia; Coronary Disease; Hemorrhage

Interventions

Aspirin; Clopidogrel; Anticoagulants; Anti-Inflammatory Agents, Non-Steroidal; Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

GB (1)