To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in pictorial bleeding assessment chart (PBAC)-score, a validated
score for assessing HMB, before randomisation (i.e. while on factor Xa
treatment) compared to the PBAC-score after randomisation. The primary analysis
is a comparison of the mean PBAC-score before randomization (i.e. while on
factor Xa treatment) with the mean PBAC-score after the participant has
switched to dabigatran.
Secondary outcome
- Quality of life assessment, by means of the disease-specific menstrual
bleeding questionnaire (MBQ) and a standardized 36-item short form survey
(SF-36) for Quality-of-Life assessment
- Laboratory values, including haemoglobin and iron-status at baseline and end
of study
- Any bleeding event other than heavy menstrual bleeding
- Any event requiring a change in anticoagulant treatment, i.e. a newly onset
thromboembolic event while on anticoagulant treatment, interruption of
anticoagulant treatment before minor or major surgical procedures
Background summary
Treatment with direct oral anticoagulants (DOACs), in particular factor Xa
inhibitors, is associated with an increased risk of abnormal uterine bleeding,
particularly heavy menstrual bleeding (HMB), in premenopausal women. It has
been suggested that abnormal uterine bleeding, including HMB and intermenstrual
bleeding, occurs less frequently during treatment with the thrombin inhibitor
dabigatran. The association between the type of DOACs (factor Xa versus
thrombin inhibitor) and HMB has not been fully elucidated and merely
assumptions on possible mechanisms exist. Use of tranexamic acid during the
menstrual period may be effective in patients with HMB, but prospective data
regarding safety in patients with an indication for anticoagulant treatment are
lacking. DOACs are prescribed increasingly and a direct comparison between
dabigatran and a factor Xa inhibitor, as well as an evaluation of the effects
of additional tranexamic acid in women with HMB is highly relevant for clinical
practice.
Study objective
To evaluate management strategies in premenopausal women with heavy menstrual
bleeding associated with factor Xa inhibitor therapy.
Study design
Randomised controlled trial.
Intervention
Eligible patients will be randomised in a 1:1:1 ratio to switch to dabigatran,
to continue treatment with the factor Xa inhibitor without intervention, or to
continue treatment with the factor Xa inhibitor with the addition of 1 gram
tranexamic acid three times a day during the first four days of the menstrual
period.
Study burden and risks
Study procedures will coincide with routine clinical care for anticoagulated
patients with HMB and potentially eligible patients will undergo extensive
evaluation of HMB as part of standard medical practice. Participants will be
asked to fill out the PBAC-assessment and a menstrual bleeding questionnaire,
which will be evaluated in a monthly telephone call for study follow-up. The
risk and burden of these assessments are small.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- premenopausal women
- age *18 years
- anticoagulant treatment with a factor Xa inhibitor
- indication for anticoagulant treatment >3months after inclusion
- heavy menstrual bleeding and a PBAC-score >150
- use of adequate contraceptive methods during study participation (this is
advised to any woman on factor Xa inhibitors during fertile ages, regardless of
study participation)
Exclusion criteria
- PBAC-score *150
- postmenopausal women; women >12 consecutive months of spontaneous amenorrhea
- concomitant use of hormonal therapy as a new intervention for HMB
- pregnancy or currently planning for pregnancy
- active malignancy or treatment with chemotherapy/radiotherapy
- cervical preneoplastic lesions
- contra indication for the registered products dabigatran or tranexamic acid
- any condition that, as judged by investigator, would place the subject at an
increased risk of harm if she participated in the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-002138-35-NL |
| CCMO | NL70177.018.19 |