Trial Outcomes & Findings for Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque (NCT NCT02090075)

NCT ID: NCT02090075

Last Updated: 2019-04-23

Results Overview

amount of calcification measured by Agatston Score. The range of values for the Agatston score is 0-10000. Higher score is worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

66 participants

Primary outcome timeframe

1 year

Results posted on

2019-04-23

Participant Flow

Participant milestones

Participant milestones
Measure	Apixaban apixaban 5 mg or 2.5 mg po bid apixaban: 5 po or 2.5 po bid.	Warfarin warfarin with target INR of 2-3 warfarin
Overall Study STARTED	33	33
Overall Study COMPLETED	26	30
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Apixaban n=33 Participants apixaban 5 mg or 2.5 mg po bid apixaban: 5 po or 2.5 po bid.	Warfarin n=33 Participants warfarin with target INR of 2-3 warfarin	Total n=66 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	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 2.4 • n=5 Participants	60 years STANDARD_DEVIATION 1.9 • n=7 Participants	57 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	23 Participants n=7 Participants	42 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	3 Participants n=5 Participants	5 Participants n=7 Participants	8 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	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	15 Participants n=7 Participants	35 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	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
coronary calcium	33 participants with coronary calcium n=5 Participants	33 participants with coronary calcium n=7 Participants	66 participants with coronary calcium n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: all with follow up scans

amount of calcification measured by Agatston Score. The range of values for the Agatston score is 0-10000. Higher score is worse outcome.

Outcome measures

Outcome measures
Measure	Apixaban n=26 Participants apixaban 5 mg or 2.5 mg po bid apixaban: 5 po or 2.5 po bid.	Warfarin n=30 Participants warfarin with target INR of 2-3 warfarin
Coronary Artery Calcium (CAC) Score	66 units on a scale Standard Deviation 129.9	31 units on a scale Standard Deviation 61.5

SECONDARY outcome

Timeframe: 1 year

Population: all participants with follow up data

To evaluate if treatment with apixaban therapy, as compared to warfarin therapy, will modify the progression, regression and stabilization of coronary atherosclerosis. Modifications will include differences in plaque volume, composition and arterial remodeling; as well as new atherosclerosis formation. The scale is based upon volume of plaque in the coronary arteries, with zero being no plaque and a higher number being more plaque. There is no scale or maximum measure, this is a linear measure of atherosclerosis volume in the coronary arteries and more is worse. None is best, any plaque is considered worse, and a higher plaque volume represents more atherosclerosis. An individual of average health will have a score of 50.

Outcome measures

Outcome measures
Measure	Apixaban n=26 Participants apixaban 5 mg or 2.5 mg po bid apixaban: 5 po or 2.5 po bid.	Warfarin n=30 Participants warfarin with target INR of 2-3 warfarin
Coronary Plaque on CT Angiography	47 units on a scale Standard Deviation 52	54 units on a scale Standard Deviation 120

Adverse Events

Apixaban

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Warfarin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Matthew Budoff

Los Angeles Biomedical Research Institute at Harbo

Phone: 3102224107

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place