Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation

Withdrawn

• Conditions: Non-valvular Atrial Fibrillation

• Registration Number: NCT03002740
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

In a population of patients with non-valvular atrial fibrillation (NVAF), and treated with oral anticoagulants (OAC) in routine clinical practice in England, this study will describe patients treated with each OAC, and to estimate and compare event rates of treatment discontinuation, bleeding, and healthcare resource utilisation (HCRU) across OAC treatments.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-31
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Have a prescription for apixaban, rivaroxaban, dabigatran, or VKA during the study period
2. Are ≥ 18 years of age at index date
3. Have ≥ 12 months of computerised medical data prior to index date (date of OAC initiation)
4. Have a record of AF on or ever prior to index date

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Exclusion Criteria

1. Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
2. Have a history of the OACs which are prescribed during the study period (ie, history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran, or VKA)
3. Have more than 1 OAC exposure which starts on the same date

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)	Approximately 3 years

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)	Approximately 3 years
Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)	At baseline
Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)	At baseline
Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)	Approximately 3 years
Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)	Approximately 3 years	Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests