Rivaroxaban vs Apixaban on Menstrual Blood Loss

Last updated: May 20, 2016
Sponsor: Indiana University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Treatment

N/A

Clinical Study ID

NCT02761044
1604457633
  • Ages 18-49
  • Female

Study Summary

The purpose of this study is to evaluate women with heavy menstrual bleeding that have venous thromboembolism or atrial fibrillation. There will be a comparison of the anti-coagulants; drugs rivaroxaban or apixaban to see if one of the drugs works better to control bleeding during the women's menses.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-pregnant women, age <50,

  • Objectively diagnosed VTE or atrial fibrillation within the previous 30 days, and nomenstrual cycle since diagnosis

  • Patient reported active menstruation, requiring >3 menstrual periods in the previous 6 months

  • Clinical plan and patient agreement to treat with oral anticoagulation for 3 monthsor longer

  • Patients must have a working mobile phone

Exclusion

Exclusion Criteria:

  • Package insert exclusions for Eliquis or Xarelto: [active pathological bleeding orsevere hypersensitivity reaction to XARELTO or ELIQUIS (e.g., anaphylacticreactions)]

  • Plan to become pregnant in the next three months.

  • Concomitant prescribed use of aspirin or thienopyridines or other platelet inhibitingdrugs

  • Plan for surgical hysterectomy or endometrial ablation

  • Known uterine cancer

  • Von Willebrand's disease, or hemophilia

  • Known coagulopathy from liver disease

  • Conditions likely to preclude adherence to study procedures: Active intravenous druguse, known alcoholism, homelessness, or uncontrolled psychiatric illness.

Study Design

Total Participants: 308
Study Start date:
May 01, 2016
Estimated Completion Date:
May 31, 2019

Study Description

Heavy menstrual bleeding complicates the treatment of approximately nine to twenty five percent of patients treated with orally administered anti-Xa anticoagulants for venous thromboembolism, including either pulmonary embolism or deep vein thrombosis. In particular, recent evidence has suggested an increase in length and severity of menstrual bleeding for women treated with rivaroxaban, and this effect may be less severe with apixaban treatment. Increase in uterine bleeding with rivaroxaban has necessitated hysterectomy in rare cases. Other complications of heavy menstrual bleeding include reduced drug adherence, decreased perception of wellness (quality of life) and anemia. The anti-Xa agents may increase heavy menstrual bleeding more than vitamin K antagonists. However, in the principal investigators' experience treating over one hundred women of menstruating age with rivaroxaban for venous thromboembolism with varying degree of heavy menstrual bleeding, no woman has expressed desire to switch to a vitamin K antagonists even when offered this option (unpublished data). The investigators have successfully reduced perception of heavy menstrual bleeding by switching from rivaroxaban to apixaban in six patients. Comparison of published and supplemental data from large trials of apixaban versus rivaroxaban to treat venous thromboembolism reveals a lower rate of uterine bleeding with apixaban compared with rivaroxaban, although exact comparisons are difficult to make. Myers et al recently reported a 9.4 percent rate of heavy menstrual bleeding with apixaban, compared with a 25 percent rate of heavy menstrual bleeding with rivaroxaban. Accordingly, the investigators hypothesize that a larger proportion of women with menstruating potential with newly diagnosed venous thromboembolism or atrial fibrillation, treated with apixaban will have less menstrual blood loss than patients randomized to rivaroxaban.