Trial Outcomes & Findings for Warfarin and Coronary Calcification Project (NCT NCT00868712)
NCT ID: NCT00868712
Last Updated: 2012-08-24
Results Overview
The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; \>1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.
COMPLETED
70 participants
EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.
2012-08-24
Participant Flow
Recruitment is complete. All patients were recruited from within the Walter Reed Anticoagulation Clinic, as specified in the protocol.
Participant milestones
| Measure |
Warfarin Use Short Duration
Warfarin use for less than 6 months
|
2 - Warfarin Use Intermediate
Warfarin use for 6 to 24 months in duration
|
3 - Warfarin Use Chronic
Warfarin use \>24 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
11
|
28
|
|
Overall Study
COMPLETED
|
31
|
11
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Warfarin and Coronary Calcification Project
Baseline characteristics by cohort
| Measure |
Warfarin Use Short Duration
n=31 Participants
Warfarin use for less than 6 months
|
2 - Warfarin Use Intermediate
n=11 Participants
Warfarin use for 6 to 24 months in duration
|
3 - Warfarin Use Chronic
n=28 Participants
Warfarin use \>24 months
|
Total
n=70 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age Continuous
|
64 years
STANDARD_DEVIATION 13 • n=5 Participants
|
68 years
STANDARD_DEVIATION 11 • n=7 Participants
|
73 years
STANDARD_DEVIATION 12 • n=5 Participants
|
68 years
STANDARD_DEVIATION 13 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
70 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.Population: After interim analysis following n=70 showed no effect, further enrollment was halted.
The Agatston score is calculated using a non-contrast computed tomography (CT) scan to measure for the presence and severity of coronary artery disease through identification of calcification in the coronary arteries. Scores can range from 0 to several thousands. The measure is without units. Score categories are as follows: 0 = no coronary disease; 1-100 = low amount of coronary artery disease; 101-400 = moderately elevated score / moderate coronary artery disease; 401-1000 = severely elevated score; \>1000 very severely elevated score. Higher Agatston scores corelate with more coronary artery disease and predict a higher risk of coronary heart disease events and mortality.
Outcome measures
| Measure |
Warfarin Use Short Duration
n=31 Participants
Warfarin use for less than 6 months
|
2 - Warfarin Use Intermediate
n=11 Participants
Warfarin use for 6 to 24 months in duration
|
3 - Warfarin Use Chronic
n=28 Participants
Warfarin use \>24 months
|
|---|---|---|---|
|
Coronary Calcification (Presence and Degree as Measured by Agatston Score) Attributed to Duration of Warfarin Use in Months After Controlling for Standard Cardiovascular Risk Factors to Include the Framingham Risk Score
|
175 Agatston Score
Standard Deviation 285
|
289 Agatston Score
Standard Deviation 382
|
426 Agatston Score
Standard Deviation 789
|
SECONDARY outcome
Timeframe: EBCT scan is done at time of enrollment of patient into 1 of 3 groups based on warfarin use duration: <6 months; 6-24 months; >24 mos.The International Normalized Ratio (INR) is a standardized lab value that measures the intensity of anticogulation using warfarin. It is used to monitor patients taking warfarin.
Outcome measures
| Measure |
Warfarin Use Short Duration
n=31 Participants
Warfarin use for less than 6 months
|
2 - Warfarin Use Intermediate
n=11 Participants
Warfarin use for 6 to 24 months in duration
|
3 - Warfarin Use Chronic
n=28 Participants
Warfarin use \>24 months
|
|---|---|---|---|
|
International Normalized Ratio
|
1.8 ratio
Standard Deviation 0.9
|
2.4 ratio
Standard Deviation 0.4
|
2.5 ratio
Standard Deviation 0.4
|
Adverse Events
Warfarin Use Short Duration
2 - Warfarin Use Intermediate
3 - Warfarin Use Chronic
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Todd C. Villines, MD
Walter Reed Army Medical Center, Cardiology Service
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place