Prospective Comparison of Incidence of Heavy Menstrual Bleeding in Women Treated With Direct Oral Anticoagulants

Completed

• Conditions: Heavy Menstrual Bleeding
• Interventions: Drug: Apixaban 5 MG; Drug: Rivaroxaban 20 MG; Drug: Dabigatran 150 Mg Oral Capsule; Drug: Edoxaban 60 MG

• Registration Number: NCT04477837
• Lead Sponsor: Cardioangiologisches Centrum Bethanien

Brief Summary

Prospective comparison of the incidence of heavy menstrual bleeding (HMB) in women of reproductive age treated with direct oral anticoagulants (DOACs)

Detailed Description

Patients will be treated as standard of care, no randomization schedule, no blinded investigational product (IP).

The decision which DOAC will be given is made before the subject will enter the trial. The DOAC has to be taken at least for seven days.

The registry is non-interventional (NIS) with routine blood draw at baseline and at month 4 after inclusion. The prospective follow up will be up to four months. Three consecutive menstrual bleeding cycles will be documented by the participating patients at home. One baseline data reporting and one follow up reporting after four months are planned in the participating coagulation centers.

The primary aim is the comparison of the frequency of heavy menstrual bleeding in female patients of reproductive age anticoagulated with DOACs using a modified pictorial blood loss assessment chart.

Secondary aims are the prevalence of von Willebrand disease in young anticoagulated female patients and correlation of HMB with age, International Society of Thrombosis and Hemostasis bleeding assessment tool at inclusion, Blood group, anatomical reasons i.e. underlying uterine pathologies, i. e. presence of uterine fibroids, endometrial polyps and/or adenomyosis, occurrence of iron deficiency, hemoglobin level and intermittent use of non-steroidal anti-inflammatory drug (NSAID).

Study Timeline

• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-20
• Study Start: 2020-10-15
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

• Women with venous thromboembolism
• Age: 18 - 50 years
• Regular menstrual bleeding
• Treatment with DOACs for at least 7 days before inclusion
• Full therapeutic anticoagulation with rivaroxaban 1 x 20 mg, apixaban 2 x 5 mg, edoxaban 60mg once daily or dabigatran 2 x 150mg for at least the next four months
• Written informed consent

Exclusion Criteria

• Hysterectomy or ovariectomy
• Known heavy menstrual bleeding
• Hormonal contraceptives
• Hormone replacement therapy
• Use of hormone releasing intrauterine System (IUS)
• Contraindications to treatment with DOACs
• Treatment with rivaroxaban 15 mg twice daily (first three weeks after diagnosis of venous thrombosis) or apixaban 10 mg twice daily (first week after diagnosis of venous thrombosis)
• Treatment with rivaroxaban (10 mg or 15 mg once daily) or apixaban (2,5 mg twice daily) in reduced therapeutic dosages
• Participation in any other trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
direct oral anticoagulant (DOAC) No.1	Apixaban 5 MG	Apixaban 5mg, oral, twice daily for at least four months
direct oral anticoagulant (DOAC) No.2	Rivaroxaban 20 MG	Rivaroxaban 20mg, oral, once daily for at least four months
direct oral anticoagulant (DOAC) No.4	Dabigatran 150 Mg Oral Capsule	Dabigatran 150mg, oral, twice daily for at least four months
direct oral anticoagulant (DOAC) No.3	Edoxaban 60 MG	Edoxaban 60mg, oral, once daily for at least four months

Primary Outcome Measures

Name	Time	Method
Primary observation point (for all patients)	baseline and monthly up to month 4	Frequency of heavy menstrual bleeding in anticoagulated female patients of reproductive Age using a modified Pictorial blood loss assessment Chart (PBAC)-Score (Higham, Br J Obstet Gynaecol 1990; 97: 734-9)

Secondary Outcome Measures

Name	Time	Method
Secondary observation points (for all patients)	up to 16 weeks	Correlation of heavy menstrual bleeding with von Willebrand's disease; Age; ISTH-BAT-Score at inclusion; blood Group; anatomical reasons i.e. underlying uterine pathologies, i.e. presence of uterine fibroids, endometrial polyps and/or adenomyosis; iron deficiency; hemoglobin level; intermittent use of NSAR

Trial Locations

Locations (1)

Cardioangiology Center Bethanien (CCB); 🇩🇪 Frankfurt am Main, Germany