Trial Outcomes & Findings for RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding (NCT NCT02829957)

NCT ID: NCT02829957

Last Updated: 2023-11-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 19 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2023-11-13

Participant Flow

Participant milestones

Measure	Rivaroxaban Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Overall Study STARTED	8	11
Overall Study COMPLETED	6	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Rivaroxaban Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding

Baseline characteristics by cohort

Measure	Rivaroxaban n=8 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	11 participants n=7 Participants	19 participants n=5 Participants
d-dimer	661 ng/ml n=5 Participants	1031 ng/ml n=7 Participants	840.5 ng/ml n=5 Participants
pbac-pictoral bloodloss assessment chart	173.5 score n=5 Participants	142 score n=7 Participants	148 score n=5 Participants
hgb	12.6 g/dl n=5 Participants	13.0 g/dl n=7 Participants	12.7 g/dl n=5 Participants
Short Form Health Survey (SF-36)	57.9 Score n=5 Participants	55.4 Score n=7 Participants	55.4 Score n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The number of participants at baseline differ from those of the outcome measurements because some participants were lost to followup.

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

Outcome measures

Measure	Rivaroxaban n=6 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=10 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
PBAC Scores	292 score on a scale Interval 74.0 to 600.0	146 score on a scale Interval 3.0 to 378.0

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Rivaroxaban n=8 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Number of Participants Who Discontinued Planned Drug Administration	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 1, 2, and 3 months

Outcome measures

Measure	Rivaroxaban n=8 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Number of Patients That Held Drug for Menorrhagia	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Rivaroxaban n=8 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Number of Participants With Major Hemorrhage	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Rivaroxaban n=8 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Number of Participants With Venous Thromboembolism (VTE)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Rivaroxaban n=8 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Number of Participants Who Crossed Over to Another Anticoagulant	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Rivaroxaban n=8 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Number of Participants With Clinically Relevant Non-major Bleeding	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 3 months

Population: The number of participants at baseline differ from those of the outcome measurements because some participants were lost to followup.

Measure Description: Normal hemoglobin range for adult women - 12 - 16 g/dL. Lower levels indicate worse outcomes.

Outcome measures

Measure	Rivaroxaban n=4 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=10 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Hemoglobin Concentration	12.8 g/dl Interval 11.6 to 14.5	13.25 g/dl Interval 10.7 to 14.6

SECONDARY outcome

Timeframe: 3 months

Population: The number of participants at baseline differ from those of the outcome measurements because some participants were lost to followup.

The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Outcome measures

Measure	Rivaroxaban n=4 Participants Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=10 Participants Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Physical Component Summary of Standard From 36	55.5 Score Interval 35.6 to 75.4	45.6 Score Interval 25.8 to 80.4

Adverse Events

Rivaroxaban

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Apixaban

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rivaroxaban n=8 participants at risk Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months	Apixaban n=11 participants at risk Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Blood and lymphatic system disorders Crossover to another anticoagulant	37.5% 3/8 • Number of events 3 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.	9.1% 1/11 • Number of events 1 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.
Reproductive system and breast disorders PBAC > 100	25.0% 2/8 • Number of events 5 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.	45.5% 5/11 • Number of events 11 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.
Blood and lymphatic system disorders Anticoagulant discontinued for more than 48 hours	12.5% 1/8 • Number of events 1 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.	9.1% 1/11 • Number of events 1 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.
Vascular disorders Worsening DVT	12.5% 1/8 • Number of events 1 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.	0.00% 0/11 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.
Blood and lymphatic system disorders Bleeding that causes unplanned visit to a healthcare provider	12.5% 1/8 • Number of events 1 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.	0.00% 0/11 • Each participant was assessed for adverse events from their baseline visit through their 3-month follow-up visit.

Additional Information

Dr. Jeffrey Kline

Indiana University

Phone: 317-880-3869

Email: jefkline@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place