Frailty and health outcomes in older people initiating an oral anticoagulant

A prospective multicentre cohort study on the influence of frailty on health outcomes in older people initiating an oral anticoagulant

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616000452493

Enrollment

1000

Registered

2016-04-07

Start date

2016-07-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary objective of the study is to investigate whether frailty increases the risk of major haemorrhage / clinically significant non-major bleed in older patients initiating an oral anticoagulant. The secondary objectives are to investigate whether frailty is a risk factor for cessation of oral anticoagulants, stroke / VTE and the association between pharmacological risk factors ability to predict the primary and secondary outcomes will be investigated in frail and non-frail participants.

Interventions

Patients who are commencing therapy with an anticoagulant (either warfarin or the novel oral anticoagulants (NOACs) dabigatran, rivaroxaban, apixaban) will be followed up for 36 months or until cessation of the anticoagulant or death.

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

commencement of an oral anticoagulant in the past 4 weeks

Exclusion criteria

previous use of warfarin or other oral anticoagulants in the previous 12 months. severe hearing impairment such that the participant cannot participate in an interview or where the investigator feels that it will not be possible to collect adequate follow-up information.

Outcome results