20 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline AssessmentPrimary· Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).
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 scal
Convenience - Baseline
Group
Value
95% CI
Cohort A
86.9
± 13.31
Convenience - Visit 2
Group
Value
95% CI
Cohort A
91.7
± 10.74
Convenience - Visit 3
Group
Value
95% CI
Cohort A
95.2
± 6.48
Satisfaction - Baseline
Group
Value
95% CI
Cohort A
64.3
± 11.06
Satisfaction - Visit 2
Group
Value
95% CI
Cohort A
68.1
± 13.36
Satisfaction - Visit 3
Group
Value
95% CI
Cohort A
72.5
± 12.41
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment GroupsPrimary· Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).
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
Pre-PSM Convenience - Visit 2
Group
Value
95% CI
Cohort B - Pradaxa®
92.4
± 9.88
Cohort B - VKA
94.3
± 5.61
Pre-PSM Convenience - Visit 3
Group
Value
95% CI
Cohort B - Pradaxa®
93.9
± 8.41
Cohort B - VKA
94.3
± 6.35
Pre-PSM Satisfaction - Visit 2
Group
Value
95% CI
Cohort B - Pradaxa®
70.1
± 11.51
Cohort B - VKA
67.3
± 9.17
Pre-PSM Satisfaction - Visit 3
Group
Value
95% CI
Cohort B - Pradaxa®
73.9
± 12.05
Cohort B - VKA
75.1
± 11.95
PSM Convenience - Visit 2
Group
Value
95% CI
Cohort B - Pradaxa®
98.5
± 2.18
Cohort B - VKA
80.8
± 9.79
PSM Satisfaction - Visit 2
Group
Value
95% CI
Cohort B - Pradaxa®
71.4
± 0.00
Cohort B - VKA
64.3
± 2.02
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second AssessmentSecondary· Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).
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
Convenience - Visit 2
Group
Value
95% CI
Cohort A
91.7
± 10.74
Convenience - Visit 3
Group
Value
95% CI
Cohort A
95.2
± 6.48
Satisfaction - Visit 2
Group
Value
95% CI
Cohort A
68.1
± 13.36
Satisfaction - Visit 3
Group
Value
95% CI
Cohort A
72.5
± 12.41
Description of PACT-Q1 Items for Patients in Cohort B at BaselineSecondary· Baseline
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? Q
Q1
Group
Value
95% CI
Cohort B - Pradaxa®
3.2
± 1.13
Cohort B - VKA
3.0
± 0.99
Q2
Group
Value
95% CI
Cohort B - Pradaxa®
3.2
± 1.19
Cohort B - VKA
3.1
± 1.11
Q3
Group
Value
95% CI
Cohort B - Pradaxa®
2.3
± 1.09
Cohort B - VKA
2.1
± 1.00
Q4
Group
Value
95% CI
Cohort B - Pradaxa®
3.6
± 1.15
Cohort B - VKA
3.7
± 1.21
Q5
Group
Value
95% CI
Cohort B - Pradaxa®
2.8
± 1.42
Cohort B - VKA
2.7
± 1.54
Q6
Group
Value
95% CI
Cohort B - Pradaxa®
3.7
± 1.12
Cohort B - VKA
3.7
± 1.09
Q7
Group
Value
95% CI
Cohort B - Pradaxa®
2.4
± 1.39
Cohort B - VKA
1.9
± 1.21
Adverse events — posted to ClinicalTrials.gov
Time frame: From signing the informed consent till end of the study; up to 210 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT04592822 — A Single Dose Bioequivalence Study of WD-1602 Versus Pradaxa® in Healthy Subjects Under Fed Condition
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 24 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03187197.