RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Cardiology, Women's Studies |
Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 12/21/2018 |
Start Date: | September 2016 |
End Date: | December 2025 |
Contact: | Kate Pettit |
Email: | klpettit@iu.edu |
Phone: | 317-962-1190 |
Randomized Trial to Test the Effect of Rivaroxaban or Apixaban on Menstrual Blood Loss in Women
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.
fibrillation, treated with apixaban will have less menstrual blood loss than patients
randomized to rivaroxaban.
Inclusion Criteria:
- Non-pregnant women, age 18-50,
- Objectively diagnosed VTE or atrial fibrillation within the previous 30 days, and no
menstrual 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 months or
longer
- Patients must have a working mobile phone
Exclusion Criteria:
- Package insert exclusions for Eliquis (Apixaban) 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 thienopyridine 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.
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