Trial Outcomes & Findings for Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation (NCT NCT03187197)
NCT ID: NCT03187197
Last Updated: 2020-02-24
Results Overview
The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
COMPLETED
1315 participants
Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).
2020-02-24
Participant Flow
This non-interventional study enrolled patients in Taiwan with a previous Vitamin K Antagonist (VKA) therapy, followed by switching to Pradaxa® (one of the novel oral anticoagulants (NOACs)) or patients being newly diagnosed with Non-Valvular Atrial Fibrillation (NVAF) and initiated on Pradaxa® or VKA.
Data was collected from approximately 20 medical centers or regional hospitals in Taiwan where Pradaxa® is taken as the prescription of stroke prophylaxis (or prevention) in Atrial Fibrillation (AF). Data was collected between June 23, 2017 and Jan 11, 2019. 10 enrolled participants were removed due to screening failures before entering the study.
Participant milestones
| Measure |
Cohort A
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - Pradaxa®
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
|
Cohort B - VKA
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
|---|---|---|---|
|
Overall Study
STARTED
|
153
|
1097
|
55
|
|
Overall Study
Started (Eligible Participants as FAS)
|
139
|
1052
|
54
|
|
Overall Study
COMPLETED
|
107
|
704
|
32
|
|
Overall Study
NOT COMPLETED
|
46
|
393
|
23
|
Reasons for withdrawal
| Measure |
Cohort A
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - Pradaxa®
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
|
Cohort B - VKA
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
|---|---|---|---|
|
Overall Study
Stopped Pradaxa®/VKA
|
11
|
65
|
4
|
|
Overall Study
Withdrawal by Subject
|
8
|
63
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
60
|
7
|
|
Overall Study
Adverse Event
|
6
|
29
|
0
|
|
Overall Study
Death
|
0
|
11
|
0
|
|
Overall Study
Administrative problem
|
1
|
1
|
0
|
|
Overall Study
Reason not listed
|
2
|
54
|
1
|
|
Overall Study
Missing
|
1
|
32
|
3
|
|
Overall Study
Status missing
|
2
|
33
|
3
|
|
Overall Study
NA in incl/excl criteria, not analyzed.
|
14
|
45
|
1
|
Baseline Characteristics
Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Cohort A
n=139 Participants
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - Pradaxa®
n=1052 Participants
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
|
Cohort B - VKA
n=54 Participants
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
Total
n=1245 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.4 Years
STANDARD_DEVIATION 15.65 • n=5 Participants
|
71.5 Years
STANDARD_DEVIATION 13.08 • n=7 Participants
|
67.1 Years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
71.0 Years
STANDARD_DEVIATION 13.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
431 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
505 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
621 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
740 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=5 Participants
|
1052 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
1245 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
139 Participants
n=5 Participants
|
1052 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
1245 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).Population: FAS
The PACT-Q was a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed(reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores were more favorable. The two dimension scores were presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Outcome measures
| Measure |
Cohort A
n=139 Participants
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - VKA
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
|---|---|---|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Convenience - Baseline
|
86.9 Units on Scale
Standard Deviation 13.31
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Convenience - Visit 2
|
91.7 Units on Scale
Standard Deviation 10.74
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Convenience - Visit 3
|
95.2 Units on Scale
Standard Deviation 6.48
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Satisfaction - Baseline
|
64.3 Units on Scale
Standard Deviation 11.06
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Satisfaction - Visit 2
|
68.1 Units on Scale
Standard Deviation 13.36
|
—
|
|
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Satisfaction - Visit 3
|
72.5 Units on Scale
Standard Deviation 12.41
|
—
|
PRIMARY outcome
Timeframe: Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).Population: FAS
The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching (PSM) method was used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group was summarized and used for comparison.
Outcome measures
| Measure |
Cohort A
n=1052 Participants
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - VKA
n=54 Participants
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
|---|---|---|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Pre-PSM Convenience - Visit 2
|
92.4 Units on Scale
Standard Deviation 9.88
|
94.3 Units on Scale
Standard Deviation 5.61
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Pre-PSM Convenience - Visit 3
|
93.9 Units on Scale
Standard Deviation 8.41
|
94.3 Units on Scale
Standard Deviation 6.35
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Pre-PSM Satisfaction - Visit 2
|
70.1 Units on Scale
Standard Deviation 11.51
|
67.3 Units on Scale
Standard Deviation 9.17
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Pre-PSM Satisfaction - Visit 3
|
73.9 Units on Scale
Standard Deviation 12.05
|
75.1 Units on Scale
Standard Deviation 11.95
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
PSM Convenience - Visit 2
|
98.5 Units on Scale
Standard Deviation 2.18
|
80.8 Units on Scale
Standard Deviation 9.79
|
|
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
PSM Satisfaction - Visit 2
|
71.4 Units on Scale
Standard Deviation 0.00
|
64.3 Units on Scale
Standard Deviation 2.02
|
SECONDARY outcome
Timeframe: Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).Population: FAS
The PACT-Q2 was composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores were more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Outcome measures
| Measure |
Cohort A
n=139 Participants
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - VKA
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
|---|---|---|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Convenience - Visit 3
|
95.2 Units on scale
Standard Deviation 6.48
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Convenience - Visit 2
|
91.7 Units on scale
Standard Deviation 10.74
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Satisfaction - Visit 2
|
68.1 Units on scale
Standard Deviation 13.36
|
—
|
|
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Satisfaction - Visit 3
|
72.5 Units on scale
Standard Deviation 12.41
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: FAS
The PACT-Q1 was composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items were: Q1: How confident are you that your anticoagulant treatment will prevent blood clots? Q2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? Q3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? Q4: How important is it for you to have an anticoagulant treatment that is easy to take? Q5: How concerned are you about making mistakes when taking your anticoagulant treatment? Q6: How important is it for you to take care of your anticoagulant treatment by yourself? Q7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/Completely/Very much).
Outcome measures
| Measure |
Cohort A
n=1052 Participants
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - VKA
n=54 Participants
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
|---|---|---|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Q1
|
3.2 Units on scale
Standard Deviation 1.13
|
3.0 Units on scale
Standard Deviation 0.99
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Q2
|
3.2 Units on scale
Standard Deviation 1.19
|
3.1 Units on scale
Standard Deviation 1.11
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Q3
|
2.3 Units on scale
Standard Deviation 1.09
|
2.1 Units on scale
Standard Deviation 1.00
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Q4
|
3.6 Units on scale
Standard Deviation 1.15
|
3.7 Units on scale
Standard Deviation 1.21
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Q5
|
2.8 Units on scale
Standard Deviation 1.42
|
2.7 Units on scale
Standard Deviation 1.54
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Q6
|
3.7 Units on scale
Standard Deviation 1.12
|
3.7 Units on scale
Standard Deviation 1.09
|
|
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Q7
|
2.4 Units on scale
Standard Deviation 1.39
|
1.9 Units on scale
Standard Deviation 1.21
|
Adverse Events
Cohort A
Cohort B - Pradaxa®
Cohort B - VKA
Serious adverse events
| Measure |
Cohort A
n=148 participants at risk
Patients with a diagnosis of NVAF, who were using VKA therapy for at least 3 months for stroke prevention before entering the study and were switched to Pradaxa®, received 110 or 150 milligram (mg) Pradaxa® capsules twice daily.
|
Cohort B - Pradaxa®
n=978 participants at risk
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke and initiated 110 or 150 mg Pradaxa® capsules twice daily.
|
Cohort B - VKA
n=48 participants at risk
Patients newly diagnosed with NVAF, not previously treated with an anticoagulant for the prevention of stroke, and initiated VKA therapy. The choice of VKA and the appropriate dosing was at the discretion of the physician.
|
|---|---|---|---|
|
Nervous system disorders
Embolic stroke
|
0.68%
1/148 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.00%
0/978 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.00%
0/48 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
|
Infections and infestations
Septic shock
|
0.00%
0/148 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.10%
1/978 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.00%
0/48 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/148 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.10%
1/978 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.00%
0/48 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
|
General disorders
Death
|
0.00%
0/148 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.20%
2/978 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
0.00%
0/48 • From signing the informed consent till end of the study; up to 210 days.
For AE reporting the safety set included all enrolled subjects with at least one actual follow-up. Following the updated Guidelines, the cardiologists treat participants using NOAC rather than VKA. There is a a major difference of patients included in the various cohorts ; this can be explained by the fact that it is a non-interventional, observational study. Which kind of treatment patients received was based on the investigators' decision according to the patient clinical situation.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER