RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Apixaban; Rivaroxaban

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.