RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
(RAMBLE)
Randomized Trial to Test the Effect of Rivaroxaban or Apixaban on Menstrual Blood Loss in Women
1 other identifier
interventional
19
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2016
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2020
CompletedResults Posted
Study results publicly available
May 10, 2023
CompletedNovember 13, 2023
October 1, 2023
3.5 years
July 6, 2016
January 14, 2021
October 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
PBAC Scores
Measure Description: A PBAC Score of \< 100 indicates a normal menstrual cycle. The lowest possible score would be zero. Higher values indicate worse outcomes. The higher theoretical range value cannot be calculated. The scoring mechanism is as follows; Towels * 1 point for each lightly stained towel * 5 points or each moderately soiled towel * 20 points if the towel is completely saturated with blood Tampons * 1 point for each lightly stained tampon * 5 points for each moderately soiled tampon * 10 points if the tampon is completely saturated with blood Clots * 1 point for small clots * 5 points for large clots
3 months
Secondary Outcomes (8)
Number of Participants Who Discontinued Planned Drug Administration
3 months
Number of Patients That Held Drug for Menorrhagia
1, 2, and 3 months
Number of Participants With Major Hemorrhage
3 months
Number of Participants With Venous Thromboembolism (VTE)
3 months
Number of Participants Who Crossed Over to Another Anticoagulant
3 months
- +3 more secondary outcomes
Study Arms (2)
Rivaroxaban
ACTIVE COMPARATORApixaban
ACTIVE COMPARATORInterventions
15mg BID for 7 days, then 20mg daily for three months
Eligibility Criteria
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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eskenazi Health System
Indianapolis, Indiana, 46202, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Related Publications (9)
De Crem N, Peerlinck K, Vanassche T, Vanheule K, Debaveye B, Middeldorp S, Verhamme P, Peetermans M. Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists. Thromb Res. 2015 Oct;136(4):749-53. doi: 10.1016/j.thromres.2015.07.030. Epub 2015 Aug 4.
PMID: 26272306BACKGROUNDMyers B, Webster A. Heavy menstrual bleeding on Rivaroxaban - Comparison with Apixaban. Br J Haematol. 2017 Mar;176(5):833-835. doi: 10.1111/bjh.14003. Epub 2016 Mar 11. No abstract available.
PMID: 26970315BACKGROUNDBeam DM, Kahler ZP, Kline JA. Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis. Acad Emerg Med. 2015 Jul;22(7):788-95. doi: 10.1111/acem.12711. Epub 2015 Jun 25.
PMID: 26113241BACKGROUNDKline JA, Kahler ZP, Beam DM. Outpatient treatment of low-risk venous thromboembolism with monotherapy oral anticoagulation: patient quality of life outcomes and clinician acceptance. Patient Prefer Adherence. 2016 Apr 15;10:561-9. doi: 10.2147/PPA.S104446. eCollection 2016.
PMID: 27143861BACKGROUNDLiu Z, Doan QV, Blumenthal P, Dubois RW. A systematic review evaluating health-related quality of life, work impairment, and health-care costs and utilization in abnormal uterine bleeding. Value Health. 2007 May-Jun;10(3):183-94. doi: 10.1111/j.1524-4733.2007.00168.x.
PMID: 17532811BACKGROUNDAgnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.
PMID: 23808982BACKGROUNDEINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.
PMID: 21128814BACKGROUNDEINSTEIN-PE Investigators; Buller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.
PMID: 22449293BACKGROUNDAgnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.
PMID: 23216615BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Terminated secondary to low rate of enrollment despite extraordinary recruitment efforts.
Results Point of Contact
- Title
- Dr. Jeffrey Kline
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey A Kline, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 12, 2016
Study Start
September 1, 2016
Primary Completion
February 13, 2020
Study Completion
February 13, 2020
Last Updated
November 13, 2023
Results First Posted
May 10, 2023
Record last verified: 2023-10