WithdrawnNot Applicable

Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)

Stopped: Study was discontinued in 2018 as sufficient sample size was not met.

United States0Started 2017-09-01

Plain-language summary

Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment) * Incident prescription of an oral anticoagulant (index date) * Patients with at least one year of computerized data prior to index date Exclusion Criteria: * Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes * Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index Other protocol defined inclusion/exclusion criteria could apply

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of major bleeding

Timeframe: At the end of 1 year

Incidence of intracranial bleeding

Timeframe: At the end of 1 year

Incidence of gastrointestinal bleeding

Timeframe: At the end of 1 year

Incidence of clinically relevant non-major bleeding

Timeframe: At the end of 1 year

Incidence of ischemic stroke

Timeframe: At the end of 1 year

Incidence of unspecified stroke

Timeframe: At the end of 1 year

Incidence of systemic embolic events

Timeframe: At the end of 1 year

Trial details

NCT IDNCT03508258

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-09-01

View on ClinicalTrials.gov More Non-valvular Atrial Fibrillation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of major bleeding

Timeframe: At the end of 1 year

Incidence of intracranial bleeding

Timeframe: At the end of 1 year

Incidence of gastrointestinal bleeding

Timeframe: At the end of 1 year

Incidence of clinically relevant non-major bleeding

Timeframe: At the end of 1 year

Incidence of ischemic stroke

Timeframe: At the end of 1 year

Incidence of unspecified stroke

Timeframe: At the end of 1 year

Incidence of systemic embolic events

Timeframe: At the end of 1 year