RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Completed · Phase 2/Phase 3
Conditions studied: Venous Thromboembolism, Menstruation
In brief
A large proportion of women with menstruating potential with newly diagnosed VTE or atrial fibrillation, treated with apixaban will have less menstrual blood loss than patients randomized to rivaroxaban.
Key facts
- Study ID
- NCT02829957
- Run by
- Indiana University
- People needed
- 19
- Starts
- 2016-09-01
- Expected to finish
- 2020-02-13
- Last updated by the study team
- 2023-11-13
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Non-pregnant women, age 18-50
- For study purposes, evidence of negative pregnancy is accounted for by the treating physician's initiation of treatment with oral anticoagulants
- Objectively diagnosed VTE or atrial fibrillation/flutter
- Patient reported active menstruation - does not apply to women who were recently pregnant
- Clinical plan and patient agreement to treat with oral anticoagulation for 3 months or longer
- Patients must have a working telephone
You may not qualify if…
- Package insert exclusions for Eliquis (Apixban) or Xarelto (Rivaroxaban): [active pathological bleeding or severe hypersensitivity reaction to XARELTO or ELIQUIS (e.g., anaphylactic reactions)]
- Plan to become pregnant in the next three months.
- Concomitant prescribed use of aspirin or thienopyridenes or other platelet inhibiting drugs
- 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 drug use, known alcoholism, homelessness, or uncontrolled psychiatric illness.
Where it is running
- Eskenazi Health System — Indianapolis, Indiana, United States
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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