DAME study: Dabigatran versus apixaban effect on heavy menstrual bleeding (HMB) evaluation in women of childbearing age

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625001340426

Acronym

DAME

Enrollment

660

Registered

2025-12-02

Start date

2026-01-05

Completion date

2031-01-06

Last updated

2025-12-08

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

Conditions

None listed

Brief summary

Heavy menstrual bleeding (HMB) in women of childbearing age on anticoagulation is likely under-reported, but is a significant issue. Studies to date suggest that oral factor Xa inhibitors may be associated with a higher risk of HMB than direct thrombin inhibitors, and that dabigatran is likely to be associated with less HMB than apixaban, however more data is required to confirm this. If a particular class of anticoagulant can be demonstrated to have a lower incidence of HMB, then this could be useful to guide clinicians as to which anticoagulant to use in women of childbearing age requiring anticoagulation, particularly those who have pre-existing issues with HMB. We aim to prospectively collect data on women of childbearing age on anticoagulation for VTE (venous thromboembolism), recording their menstrual bleeding both at baseline and after six months of anticoagulation. We will compare HMB rates on dabigatran and apixaban. The data on apixaban will be collected mainly from our collaborating centre/s in the UK and Australia, as apixaban is not funded for VTE in NZ.

Interventions

All patients enrolled in NZ will receive Clexane treatment dose 1mg/kg BD or 1.5mg/kg once daily (subcutaneous) for five days then oral dabigatran 150mg BD for 3-6 months. Adherence will not be formerly assessed.

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

• Menstruating women/adolescents aged 16 years or older with acute symptomatic venous thromboembolism, provoked or unprovoked, being treated with full dose apixaban or dabigatran for a minimum of three months duration.

Exclusion criteria

• Pregnant/breastfeeding women • Post-menopausal women • CreCl <25ml/min for apixaban group, Cre Cl 2x ULN • Platelets <50 • Patients already on anticoagulation or antiplatelet agents prior to new VTE event • Planned courses of anticoagulation for <6 months • Patients receiving treatment with reduced doses of anticoagulants or variations in treatment dosing or duration including LMWH

Outcome results