Phase 3
N=19
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Venous Thromboembolism · Menstruation
Bottom Line
View on ClinicalTrials.gov: NCT02829957 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: PBAC Scores — 292; 146 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Apixaban (Drug); Rivaroxaban (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PBAC Scores |
292; 146 | — |
| SECONDARY Number of Participants Who Discontinued Planned Drug Administration |
4; 2 | — |
| SECONDARY Number of Patients That Held Drug for Menorrhagia |
0; 0 | — |
| SECONDARY Number of Participants With Major Hemorrhage |
0; 0 | — |
| SECONDARY Number of Participants With Venous Thromboembolism (VTE) |
0; 0 | — |
| SECONDARY Number of Participants Who Crossed Over to Another Anticoagulant |
3; 1 | — |
| SECONDARY Number of Participants With Clinically Relevant Non-major Bleeding |
3; 0 | — |
| SECONDARY Hemoglobin Concentration |
12.8; 13.25 | — |
| SECONDARY Physical Component Summary of Standard From 36 |
55.5; 45.6 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02829957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.