Trial Outcomes & Findings for Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium (NCT NCT02376010)
NCT ID: NCT02376010
Last Updated: 2024-10-15
Results Overview
serial calcium scans
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
110 participants
Primary outcome timeframe
1 year
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Rivaroxaban
rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)
rivaroxaban
|
Warfarin
warfarin orally once a day, titrated to INR of 2-3
Warfarin
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
46
|
51
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium
Baseline characteristics by cohort
| Measure |
Rivaroxaban
n=55 Participants
rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)
rivaroxaban
|
Warfarin
n=55 Participants
warfarin orally once a day, titrated to INR of 2-3
Warfarin
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 10 • n=99 Participants
|
60 years
STANDARD_DEVIATION 11 • n=107 Participants
|
61 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: patients completed second scan with interpretable data
serial calcium scans
Outcome measures
| Measure |
Rivaroxaban
n=46 Participants
rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)
rivaroxaban
|
Warfarin
n=51 Participants
warfarin orally once a day, titrated to INR of 2-3
Warfarin
|
|---|---|---|
|
Coronary Artery Calcium (Serial Calcium Scans)
|
26.3 mm cubed
Interval 4.5 to 61.5
|
40.5 mm cubed
Interval 9.6 to 97.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: volume of plaque in patients completing study
measures of total atherosclerosis plaque on serial CCTA
Outcome measures
| Measure |
Rivaroxaban
n=46 Participants
rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)
rivaroxaban
|
Warfarin
n=51 Participants
warfarin orally once a day, titrated to INR of 2-3
Warfarin
|
|---|---|---|
|
Atherosclerotic Plaque (Measures of Total Atherosclerosis Plaque on Serial CCTA)
|
20.1 mm cubed
Interval 0.0 to 45.0
|
30.1 mm cubed
Interval 2.0 to 72.0
|
Adverse Events
Rivaroxaban
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Warfarin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rivaroxaban
n=46 participants at risk
rivaroxaban will be given to this cohort, once daily orally (15 or 20 mg, depending on GFR)
rivaroxaban
|
Warfarin
n=51 participants at risk
warfarin orally once a day, titrated to INR of 2-3
Warfarin
|
|---|---|---|
|
Blood and lymphatic system disorders
minor bleeding
|
2.2%
1/46 • Number of events 1 • 1 year
|
3.9%
2/51 • Number of events 2 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place