Trial · NCT03187197
Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
NCT03187197, Completed, Boehringer Ingelheim; results first posted 2020-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation. Trials, record NCT03187197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03187197
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
- NCT number
- NCT03187197
- Status
- Completed
- Enrollment
- 1,315 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- Pradaxa®
- First posted
- 2017-06-14
- Last updated
- 2020-02-24
- Results first posted
- 2020-02-24
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | 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 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). |
| Primary | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | 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 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. |
| Secondary | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | 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 more favorable. The two dimension scores were presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). |
| Secondary | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | 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? 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®). | FAS | Units on Scale | MEAN |
| PRIMARY | Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA). | FAS | Units on Scale | MEAN |
| SECONDARY | Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment | Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®). | FAS | Units on scale | MEAN |
| SECONDARY | Description of PACT-Q1 Items for Patients in Cohort B at Baseline | Baseline | FAS | Units on scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Cohort A | Convenience - Baseline | 86.9 | Standard Deviation 13.31 | Units on Scale |
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Cohort A | Convenience - Visit 2 | 91.7 | Standard Deviation 10.74 | Units on Scale |
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Cohort A | Convenience - Visit 3 | 95.2 | Standard Deviation 6.48 | Units on Scale |
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Cohort A | Satisfaction - Baseline | 64.3 | Standard Deviation 11.06 | Units on Scale |
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Cohort A | Satisfaction - Visit 2 | 68.1 | Standard Deviation 13.36 | Units on Scale |
| Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment | Cohort A | Satisfaction - Visit 3 | 72.5 | Standard Deviation 12.41 | Units on Scale |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Cohort B - Pradaxa® | Pre-PSM Convenience - Visit 2 | 92.4 | Standard Deviation 9.88 | Units on Scale |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Cohort B - VKA | Pre-PSM Convenience - Visit 2 | 94.3 | Standard Deviation 5.61 | Units on Scale |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Cohort B - Pradaxa® | Pre-PSM Convenience - Visit 3 | 93.9 | Standard Deviation 8.41 | Units on Scale |
| Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups | Cohort B - VKA | Pre-PSM Convenience - Visit 3 | 94.3 | Standard Deviation 6.35 | Units on Scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A | 153 | |
| Overall Study | STARTED | Cohort B - Pradaxa® | 1,097 | |
| Overall Study | STARTED | Cohort B - VKA | 55 | |
| Overall Study | Started (Eligible Participants as FAS) | Cohort A | 139 | |
| Overall Study | Started (Eligible Participants as FAS) | Cohort B - Pradaxa® | 1,052 | |
| Overall Study | Started (Eligible Participants as FAS) | Cohort B - VKA | 54 | |
| Overall Study | COMPLETED | Cohort A | 107 | |
| Overall Study | COMPLETED | Cohort B - Pradaxa® | 704 | |
| Overall Study | COMPLETED | Cohort B - VKA | 32 | |
| Overall Study | NOT COMPLETED | Cohort A | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Embolic stroke | Nervous system disorders | Cohort A | 1 | 148 | |
| serious | Embolic stroke | Nervous system disorders | Cohort B - Pradaxa® | 0 | 978 | |
| serious | Embolic stroke | Nervous system disorders | Cohort B - VKA | 0 | 48 | |
| serious | Septic shock | Infections and infestations | Cohort A | 0 | 148 | |
| serious | Septic shock | Infections and infestations | Cohort B - Pradaxa® | 1 | 978 | |
| serious | Septic shock | Infections and infestations | Cohort B - VKA | 0 | 48 | |
| serious | Gastric ulcer haemorrhage | Gastrointestinal disorders | Cohort A | 0 | 148 | |
| serious | Gastric ulcer haemorrhage | Gastrointestinal disorders | Cohort B - Pradaxa® | 1 | 978 | |
| serious | Gastric ulcer haemorrhage | Gastrointestinal disorders | Cohort B - VKA | 0 | 48 | |
| serious | Death | General disorders | Cohort A | 0 | 148 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A | 0 | 148 |
| Total, all-cause mortality | Cohort B - Pradaxa® | 11 | 978 |
| Total, all-cause mortality | Cohort B - VKA | 0 | 48 |
| Total, other adverse events | Cohort A | 0 | 148 |
| Total, other adverse events | Cohort B - Pradaxa® | 0 | 978 |
| Total, other adverse events | Cohort B - VKA | 0 | 48 |
| Total, serious adverse events | Cohort A | 1 | 148 |
| Total, serious adverse events | Cohort B - Pradaxa® | 4 | 978 |
| Total, serious adverse events | Cohort B - VKA | 0 | 48 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33784265 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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