Trial Outcomes & Findings for Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients (NCT NCT00356759)
NCT ID: NCT00356759
Last Updated: 2018-08-22
Results Overview
Percent time in therapeutic range calculated by linear interpolation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
250 participants
Primary outcome timeframe
12 months
Results posted on
2018-08-22
Participant Flow
Participant milestones
| Measure |
Dose Assessment 4-weekly
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
124
|
|
Overall Study
COMPLETED
|
112
|
114
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
Dose Assessment 4-weekly
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Overall Study
Death
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Intercurrent disease or persistent extre
|
5
|
2
|
Baseline Characteristics
Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients
Baseline characteristics by cohort
| Measure |
Dose Assessment 4-weekly
n=126 Participants
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
n=124 Participants
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
72 years
n=5 Participants
|
70 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Therapeutic INR range
INR range 2.0-3.0
|
111 participants
n=5 Participants
|
109 participants
n=7 Participants
|
220 participants
n=5 Participants
|
|
Therapeutic INR range
INR range 2.5-3.5
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intention to treat population
Percent time in therapeutic range calculated by linear interpolation.
Outcome measures
| Measure |
Dose Assessment 4-weekly
n=126 Participants
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
n=124 Participants
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Primary Outcome Measure: Time in Therapeutic Range
|
74.1 percentage of time
Standard Deviation 18.8
|
71.6 percentage of time
Standard Deviation 20.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention to treat
Number of patients with any objectively verified, independently adjudicated thromboembolic event during the 12-month study period
Outcome measures
| Measure |
Dose Assessment 4-weekly
n=126 Participants
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
n=124 Participants
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Secondary Efficacy Outcomes: Thromboembolic Events
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention to treat
Number of patients with any objectively verified, independently adjudicated major bleeding event during the 12-month study period. Major bleeding was defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria
Outcome measures
| Measure |
Dose Assessment 4-weekly
n=126 Participants
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
n=124 Participants
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Secondary Safety Outcome: Major Bleeding
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention to treat
Secondary safety outcome is number of patients with at least one INR below 1.5 or above 4.4
Outcome measures
| Measure |
Dose Assessment 4-weekly
n=126 Participants
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
n=124 Participants
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Secondary Safety Outcome: Number of Patients With Extreme INR Results
|
27 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention to treat
Number of INRs outside the range 1.5-4.4
Outcome measures
| Measure |
Dose Assessment 4-weekly
n=126 Participants
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
n=124 Participants
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Number of Extreme INR Results
|
27 Number of tests
|
17 Number of tests
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intention to treat
Number of patients with at least one change of maintenance dose during the 12-month study period
Outcome measures
| Measure |
Dose Assessment 4-weekly
n=126 Participants
INRs and dose assessments every 4 weeks true values, no sham INRs
|
Dose Assessment 12-weekly
n=124 Participants
INRs and dose assessment 4-weekly, but 2 of 3 INRs are sham results, so dose assessment on true result is only 12-weekly
|
|---|---|---|
|
Patients With Dose Changes
|
70 participants
|
46 participants
|
Adverse Events
12-weekly INR
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
4-weekly INR
Serious events: 7 serious events
Other events: 4 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
12-weekly INR
n=124 participants at risk
Patients had INR every 4 weeks but only every thisrd INR was true; the other two were sham INRs dampened to be within or close to therapeutic range. Thus, true dose assessment was in practice performed every 12 weeks
|
4-weekly INR
n=126 participants at risk
Patients had INR every 4 weeks and all results were true. Thus, true dose assessments were performed every 4 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac death
|
0.81%
1/124 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
2.4%
3/126 • Number of events 3 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/124 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.81%
1/124 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
1.6%
2/124 • Number of events 2 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/124 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
Other adverse events
| Measure |
12-weekly INR
n=124 participants at risk
Patients had INR every 4 weeks but only every thisrd INR was true; the other two were sham INRs dampened to be within or close to therapeutic range. Thus, true dose assessment was in practice performed every 12 weeks
|
4-weekly INR
n=126 participants at risk
Patients had INR every 4 weeks and all results were true. Thus, true dose assessments were performed every 4 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
4/124 • Number of events 4 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
|
Renal and urinary disorders
Hematuria
|
1.6%
2/124 • Number of events 2 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.81%
1/124 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
|
Eye disorders
Subconjunctival bleeding
|
0.00%
0/124 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
0.79%
1/126 • Number of events 1 • 12 months
Fatal events are reported as serious adverse events. Non-fatal major bleeding or thromboembolism are reported as serious adverse events. Minor bleeding events are reported as non-serious (other) adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place