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

Sponsor

Cardioangiologisches Centrum Bethanien (Other)

Overall Status

Recruiting

CT.gov ID

NCT04477837

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heavy Menstrual Bleeding	Drug: Apixaban 5 MG Drug: Rivaroxaban 20 MG Drug: Edoxaban 60 MG Drug: Dabigatran 150 Mg Oral Capsule

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Incidence of Heavy Menstrual Bleeding in Women of Reproductive Age Treated With Direct Oral Anticoagulants Because of Venous Thromboembolism

Actual Study Start Date :

Oct 15, 2020

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Jun 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
direct oral anticoagulant (DOAC) No.1 Apixaban 5mg, oral, twice daily for at least four months	Drug: Apixaban 5 MG frequency of heavy menstrual bleeding Other Names: Eliquis
direct oral anticoagulant (DOAC) No.2 Rivaroxaban 20mg, oral, once daily for at least four months	Drug: Rivaroxaban 20 MG frequency of heavy menstrual bleeding Other Names: Xarelto
direct oral anticoagulant (DOAC) No.3 Edoxaban 60mg, oral, once daily for at least four months	Drug: Edoxaban 60 MG frequency of heavy menstrual bleeding Other Names: Lixiana
direct oral anticoagulant (DOAC) No.4 Dabigatran 150mg, oral, twice daily for at least four months	Drug: Dabigatran 150 Mg Oral Capsule frequency of heavy menstrual bleeding Other Names: Pradaxa

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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