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

NCT ID: NCT04477837

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2024-06-15

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).

Conditions

Heavy Menstrual Bleeding

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

direct oral anticoagulant (DOAC) No.1

Apixaban 5mg, oral, twice daily for at least four months

Apixaban 5 MG

Intervention Type: DRUG

frequency of heavy menstrual bleeding

direct oral anticoagulant (DOAC) No.2

Rivaroxaban 20mg, oral, once daily for at least four months

Rivaroxaban 20 MG

Intervention Type: DRUG

frequency of heavy menstrual bleeding

direct oral anticoagulant (DOAC) No.3

Edoxaban 60mg, oral, once daily for at least four months

Edoxaban 60 MG

Intervention Type: DRUG

frequency of heavy menstrual bleeding

direct oral anticoagulant (DOAC) No.4

Dabigatran 150mg, oral, twice daily for at least four months

Dabigatran 150 Mg Oral Capsule

Intervention Type: DRUG

frequency of heavy menstrual bleeding

Interventions

Apixaban 5 MG

frequency of heavy menstrual bleeding

Intervention Type: DRUG

Rivaroxaban 20 MG

frequency of heavy menstrual bleeding

Intervention Type: DRUG

Edoxaban 60 MG

frequency of heavy menstrual bleeding

Intervention Type: DRUG

Dabigatran 150 Mg Oral Capsule

frequency of heavy menstrual bleeding

Intervention Type: DRUG

Other Intervention Names

Eliquis; Xarelto; Lixiana; Pradaxa

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cardioangiologisches Centrum Bethanien

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. E. Lindhoff-Last

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edelgard Lindhoff-Last, Prof.

Role: PRINCIPAL_INVESTIGATOR

Cardioangiologisches Zentrum Bethanien

Locations

Cardioangiology Center Bethanien (CCB)

Frankfurt am Main, , Germany

Countries

Germany

Other Identifiers

HEMBLED

Identifier Type: -

Identifier Source: org_study_id