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

Non-valvular Atrial Fibrillation Clinical Trial

Official title:

Bleeding Events and Oral Anticoagulant Treatment in Non-Valvular Atrial Fibrillation (Heart-BEAT): A Cohort Study Based on CPRD-HES Data

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03002740
• Other study ID #: CV185-491
• Status: Withdrawn
• Start date: January 31, 2016
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative incidence of clinically relevant bleeding events following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)		Approximately 3 years
Secondary	Composite of clinical characteristics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)		At baseline
Secondary	Composite of patient demographics in patients with non-valvular atrial fibrillation (NVAF) newly prescribed oral anticoagulants (OACs)		At baseline
Secondary	Cumulative incidence of a major bleeding event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)		Approximately 3 years
Secondary	Cumulative incidence of a thromboembolic event following treatment initiation among NVAF patients newly prescribed oral anticoagulants (OACs)		Approximately 3 years
Secondary	Composite of Healthcare resource utilization patients newly prescribed oral anticoagulants (OACs)	Healthcare resource utilization corresponds to referrals, hospitalizations, prescriptions, and laboratory tests	Approximately 3 years

External Links

•   BMS Clinical Trial Information
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•   Investigator Inquiry Form