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

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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.


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.
We found this trial at
2
sites
Indianapolis, Indiana 46250
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Indianapolis, IN
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Indianapolis, Indiana 46202
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Indianapolis, IN
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