Rivaroxaban vs Apixaban on Menstrual Blood Loss — RAMBLE  

Venous Thromboembolism Clinical Trial

Official title: Randomized Trial to Test Effect of Rivaroxaban or Apixaban on Menstrual Blood Loss in Women (RAMBLE)

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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menstrual bleeding, no woman has expressed desire to switch to a vitamin K antagonists even when offered this option (unpublished data).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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

• NCT number: NCT02761044
• Study type: Interventional
• Source: Indiana University
• Contact: Jeffrey A Kline, MD
• Phone: 317-287-3007
• Email: jefkline@iu.edu
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2016
• Completion date: May 2019