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

NCT03002740 | Withdrawn

• 1 other identifier: CV185-491
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

  Approximately 3 years

Secondary Outcomes (5)

• 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 major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)

  Approximately 3 years

• 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

Study Arms (4)

NVAF patients newly prescribed apixaban

NVAF patients newly prescribed rivaroxaban

NVAF patients newly prescribed dabigatran

NVAF patients newly prescribed VKA

Eligibility Criteria

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

Study Population

Adults with NVAF recorded in the UK Clinical Practice Research Datalink(CPRD) and Hospital Episode Statistics(HES) database, and who were newly prescribed with apixaban, rivaroxaban, dabigatran or VKA from 1st December 2012 and 31st December 2015 (or up to the most recent data available).

You may qualify if:

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

You may not qualify if:

• Have a record for a valvular condition that is considered causal for AF on or ever prior to index date
• 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)
• Have more than 1 OAC exposure which starts on the same date

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Pfizer: collaborator

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 26, 2016
• Study Start: January 31, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-09