Trial Outcomes & Findings for Oral Anticoagulation Therapy Pilot Study (NCT NCT01959425)
NCT ID: NCT01959425
Last Updated: 2025-02-04
Results Overview
Composite endpoint represented by the occurrence of any major thromboembolic event (stroke \[i.e., ischemic, hemorrhagic or cryptogenic\] that is an acute onset of a focal neurologic deficit of presumed vascular origin lasting for ≥24 hours or resulting in death) or major hemorrhagic complication (major bleeding) during the 12-month Evaluation Period.
TERMINATED
PHASE4
80 participants
12 months
2025-02-04
Participant Flow
The first subject was enrolled April 17, 2013. The last subject was enrolled January 25, 2019.
This was a prospective, multicenter, randomized, controlled, two arm, 1:1 design. Enrolled subjects N=80 (subjects signed informed consent). 63 subjects underwent study procedures, 17 subjects were excluded prior to randomization. According to protocol, enrolled subjects = subjects who sign the study's informed consent form.
Participant milestones
| Measure |
Off OAT Group (Test)
Discontinuation of OAT Therapy
|
On OAT Group (Control)
Continuation of OAT Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
| Measure |
Off OAT Group (Test)
Discontinuation of OAT Therapy
|
On OAT Group (Control)
Continuation of OAT Therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Discontinued Subjects
|
6
|
4
|
Baseline Characteristics
Oral Anticoagulation Therapy Pilot Study
Baseline characteristics by cohort
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.7 Years
STANDARD_DEVIATION 5.85 • n=99 Participants
|
66.0 Years
STANDARD_DEVIATION 11.09 • n=107 Participants
|
66.9 Years
STANDARD_DEVIATION 8.79 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
52 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
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsComposite endpoint represented by the occurrence of any major thromboembolic event (stroke \[i.e., ischemic, hemorrhagic or cryptogenic\] that is an acute onset of a focal neurologic deficit of presumed vascular origin lasting for ≥24 hours or resulting in death) or major hemorrhagic complication (major bleeding) during the 12-month Evaluation Period.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Number of Participants With Occurrence of Any Major Thromboembolic Event
|
0 Number of Participants
|
0 Number of Participants
|
SECONDARY outcome
Timeframe: 12 monthsAny clinical bleed that does not meet criteria for a major hemorrhagic event during the 12-month Evaluation Period.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Percentage of Participants With Minor Bleeds
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
3.2 Percentage of Participants
Interval 0.1 to 16.7
|
SECONDARY outcome
Timeframe: 12 monthsHospitalization due to any thromboembolic or major hemorrhagic event during the 12-month Evaluation Period.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Percentage of Participants Hospitalized With Any Thromboembolic or Major Hemorrhagic Event
|
3.1 Percentage of Participants
Interval 0.1 to 16.2
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 12 monthsAll cause mortality during the 12-month Evaluation Period.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Percentage of Expired Participants
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 monthsPopulation: The number of participants analyzed at each time point reflects the number of surveys collected at that time point for each group. Participants may have refused to complete the survey, or were exited from the study prior to the visit.
The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS)
Mean Score at 12 Months
|
49.3 Points on SF-36 scale
Standard Deviation 8.60
|
50.0 Points on SF-36 scale
Standard Deviation 7.06
|
|
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS)
Mean Score at Baseline
|
49.8 Points on SF-36 scale
Standard Deviation 8.56
|
50.0 Points on SF-36 scale
Standard Deviation 8.24
|
|
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Physical Component Summary (PCS)
Mean Score at 3 Months
|
52.3 Points on SF-36 scale
Standard Deviation 6.85
|
50.3 Points on SF-36 scale
Standard Deviation 8.66
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 12 monthsPopulation: The number of participants analyzed at each time point reflects the number of surveys collected at that time point for each group. Participants may have refused to complete the survey, or were exited from the study prior to the visit.
The 36-Item Short Form Health Survey (SF-36) is a validated health-related quality of life (HRQOL) tool used to measure the physical and mental health status of the study population. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 score on the assumption that each question carries equal weight. Scores can be summed together to contribute to two summary scores, a physical component score and a mental component score. The lower the score, the more disability.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS)
Mean Score at Baseline
|
51.5 Points on SF-36 scale
Standard Deviation 8.33
|
54.8 Points on SF-36 scale
Standard Deviation 8.53
|
|
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS)
Mean Score at 12 Months
|
53.2 Points on SF-36 scale
Standard Deviation 8.70
|
53.5 Points on SF-36 scale
Standard Deviation 9.79
|
|
Mean SF-36 Quality of Life Scores of Participants at Baseline, 3 Months, and 12 Months: Mental Component Summary (MCS)
Mean Score at 3 Months
|
52.8 Points on SF-36 scale
Standard Deviation 9.94
|
53.7 Points on SF-36 scale
Standard Deviation 10.47
|
SECONDARY outcome
Timeframe: 12 monthsRecurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects with recurrence of atrial fibrillation were immediately exited from the study.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Percentage of Participants With Atrial Fibrillation Recurrence
|
18.8 Percentage of Participants
Interval 7.2 to 36.4
|
12.9 Percentage of Participants
Interval 3.6 to 29.8
|
SECONDARY outcome
Timeframe: 12 monthsRepeat ablations performed due to recurrence of atrial fibrillation during the 12-month Evaluation Period. Subjects that required a repeat ablation were immediately exited from the study.
Outcome measures
| Measure |
Off OAT Group (Test)
n=32 Participants
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 Participants
Continuation of OAT Therapy
|
|---|---|---|
|
Percentage of Participants With Repeat Ablation
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
0 Percentage of Participants
Interval 0.0 to 0.0
|
Adverse Events
Off OAT Group (Test)
On OAT Group (Control)
Serious adverse events
| Measure |
Off OAT Group (Test)
n=32 participants at risk
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 participants at risk
Continuation of OAT Therapy
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/32 • 12 Months
|
3.2%
1/31 • Number of events 1 • 12 Months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/32 • 12 Months
|
3.2%
1/31 • Number of events 1 • 12 Months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
3.1%
1/32 • Number of events 1 • 12 Months
|
0.00%
0/31 • 12 Months
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Number of events 1 • 12 Months
|
0.00%
0/31 • 12 Months
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • Number of events 1 • 12 Months
|
0.00%
0/31 • 12 Months
|
|
Injury, poisoning and procedural complications
Arterial bypass thrombosis
|
3.1%
1/32 • Number of events 1 • 12 Months
|
0.00%
0/31 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
3.1%
1/32 • Number of events 1 • 12 Months
|
0.00%
0/31 • 12 Months
|
|
Nervous system disorders
Vocal cord paralysis
|
3.1%
1/32 • Number of events 1 • 12 Months
|
0.00%
0/31 • 12 Months
|
Other adverse events
| Measure |
Off OAT Group (Test)
n=32 participants at risk
Discontinuation of OAT Therapy
|
On OAT Group (Control)
n=31 participants at risk
Continuation of OAT Therapy
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/32 • 12 Months
|
6.5%
2/31 • Number of events 2 • 12 Months
|
|
Injury, poisoning and procedural complications
Joint Fracture
|
0.00%
0/32 • 12 Months
|
6.5%
2/31 • Number of events 2 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any results communications proposed to be published or presented shall be submitted to Sponsor at least 60 days prior to public release to permit Sponsor to direct removal of any confidential information contained therein. The first results communications should be a multicenter, joint publication. If a multicenter publication is not submitted by the Sponsor or designee within 12 months of the Study conclusion, PIs may publish results from their institution in accordance with the above.
- Publication restrictions are in place
Restriction type: OTHER