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CompletedNCT02849509Updated Jul 8, 2019Results posted

Patient Convenience Study- NIS RELATE

An observational study in Atrial Fibrillation, sponsored by Boehringer Ingelheim. Completed at 50 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-08.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,313
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

02

Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 1,313 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

SEASK Patients with Non valvuar Atrial Fribrillation

Inclusion criteria

Cohort A:

  1. A. Written informed consent prior to participation
  2. A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
  3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
  4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

  1. B. Written informed consent prior to participation.
  2. B. Female and male patients >= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
  3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion criteria

Exclusion criteria:

  1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
  2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
  3. Current participation in any clinical trial of a drug or device.
  4. Current participation in an European registry on the use of oral anticoagulation in AF.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,313 participants (actual)
Patient registry
No

Groups and cohorts

  • Switch Patients / A

    Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.

    Drug: Pradaxa (dabigatran)

  • New Patients / B

    Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

    Drug: Vitamin K antagonist

Interventions

  • DrugPradaxa (dabigatran)

    Pradaxa (dabigatran etexilate)110mg or 150mg

  • DrugVitamin K antagonist

    Vitamin K antagonist or Pradaxa

06

What researchers measure

Primary outcomes

  1. Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment

    Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease \& treatment (2 items), \& anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience \& satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience \& for burden of disease and treatment were reversed (reversed score = 6 - item score), added together \& rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed \& rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.

    Time frame: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)

  2. Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment

    Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.

    Time frame: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)

  3. Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups

    Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.

    Time frame: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)

  4. Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups

    Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.

    Time frame: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)

  5. Patient Characterization at Baseline - Categorical Parameters

    Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).

    Time frame: Baseline (Visit1)

  6. Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A

    Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)

    Time frame: Baseline (Visit1)

Secondary outcomes

  1. Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score

    CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.

    Time frame: Baseline (Visit1)

  2. Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score

    HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.

    Time frame: Baseline (Visit1)

  3. Patient Characteristics at Baseline - Creatinine Clearance

    Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.

    Time frame: Baseline (Visit1)

  4. Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment

    Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 score.

    Time frame: Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)

  5. Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B

    For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively. The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation. The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).

    Time frame: Baseline (Visit1)

07

Results

Posted Jul 8, 2019
Limitations and caveats
The choice of anticoagulant treatment was at the discretion of the treating physician and independent from study participation. The planned between-country comparisons of study results could not be performed or were not meaningful when performed.

Participant flow

Participant flow — Overall Study
MilestoneCohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
Started379591343
Completed289425258
Not completed9016685
Withdrew: Worsening of disease under study111
Withdrew: Worsening of other pre-existing disease012
Withdrew: Other adverse event36418
Withdrew: Withdrawal by subject61712
Withdrew: Lost to follow-up276736
Withdrew: Other, reason not specified142925
Withdrew: No inform. on termination of pradaxa/vka6101

Outcome measures

PrimaryMean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment

Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease \& treatment (2 items), \& anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience \& satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience \& for burden of disease and treatment were reversed (reversed score = 6 - item score), added together \& rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed \& rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.

Time frame:
Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Reported as:
Mean · Unit on scale
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment
Unit on scaleCohort A (Switch Patients - Pradaxa)
Convenience dimension score: Baseline71.4 ± 21.8
Convenience dimension score: Second assessment79.6 ± 18.1
Satisfaction dimension score: Baseline61.0 ± 13.3
Satisfaction dimension score: Second assessment63.2 ± 14.6
Statistical analysis
  • Cohort A (Switch Patients - Pradaxa) · Paired t-test · p = <0.0001 (p-value of paired t-test compared to baseline)
  • Cohort A (Switch Patients - Pradaxa) · Paired t-test · p = 0.0174 (p-value of paired t-test compared to baseline)
PrimaryMean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment

Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.

Time frame:
Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Reported as:
Mean · Unit on scale
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment
Unit on scaleCohort A (Switch Patients - Pradaxa)
Convenience dimension score: Baseline71.4 ± 21.8
Convenience dimension score: Last assessment82.0 ± 16.8
Satisfaction dimension score: Baseline61.0 ± 13.3
Satisfaction dimension score: Last assessment64.4 ± 14.7
Statistical analysis
  • Cohort A (Switch Patients - Pradaxa) · Paired t-test · p = <0.0001 (p-value of paired t-test compared to baseline)
  • Cohort A (Switch Patients - Pradaxa) · Paired t-test · p = 0.0004 (p-value of paired t-test compared to baseline)
PrimaryMean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups

Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.

Time frame:
Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Reported as:
Mean · Unit on scale
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups
Unit on scaleCohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
Convenience dimension score78.4 ± 14.675.1 ± 19.6
Satisfaction dimension score61.5 ± 12.759.9 ± 13.5
Statistical analysis
  • Cohort B (New Patients - Pradaxa) vs Cohort B (New Patients - VKA) · Paired t-test · p = 0.0423 (p-value of paired t-test compared between matched Pradaxa® and VKA patients)
  • Cohort B (New Patients - Pradaxa) vs Cohort B (New Patients - VKA) · Paired t-test · p = 0.2226 (p-value of paired t-test compared between matched Pradaxa® and VKA patients)
PrimaryMean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups

Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.

Time frame:
Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Reported as:
Mean · Unit on scale
Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups
Unit on scaleCohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
Convenience dimension score80.4 ± 13.676.0 ± 18.9
Satisfaction dimension score63.9 ± 11.660.9 ± 12.8
Statistical analysis
  • Cohort B (New Patients - Pradaxa) vs Cohort B (New Patients - VKA) · Paired t-test · p = 0.0287 (p-value of paired t-test compared between matched Pradaxa® and VKA patients)
  • Cohort B (New Patients - Pradaxa) vs Cohort B (New Patients - VKA) · Paired t-test · p = 0.0300 (p-value of paired t-test compared between matched Pradaxa® and VKA patients)
PrimaryPatient Characterization at Baseline - Categorical Parameters

Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).

Time frame:
Baseline (Visit1)
Reported as:
Number · Percentage of participant
Patient Characterization at Baseline - Categorical Parameters
Percentage of participantCohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
< 65 Years25.133.253.6
>= 65 and < 75 Years40.643.329.4
>= 75 Years34.323.516.9
Female34.338.630.9
Male65.761.469.1
MH: Thromboembolism6.33.41.5
MH: Cardiovascular Conditions7.75.14.4
MH: Bleedings2.61.00.9
MH: Other Conditions5.83.73.8
CoMo: Thromboembolism9.84.77.6
CoMo: Cardiovascular Conditions64.150.940.5
CoMo: Bleedings2.42.52.3
CoMo: Other Conditions26.920.817.8
CM:Antihypertensives67.556.047.8
CM:Lipid modifying agents46.733.528.0
CM:Antithrombotic agents15.39.519.8
CM:Proton pump inhibitors16.413.97.9
CM:Amiodarone7.47.15.8
CM:H2-receptor antagonists8.77.12.0
CM:NSAIDS1.82.91.7
CM:Verapamil1.11.51.7
DoP:110 mg twice daily68.158.0—
DoP:150 mg twice daily31.942.0—
SecondaryPatient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score

CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.

Time frame:
Baseline (Visit1)
Reported as:
Mean · unit on scale
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score
unit on scaleCohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score3.1 ± 1.42.6 ± 1.42.0 ± 1.6
SecondaryPatient Characteristics at Baseline - HAS-BLED Bleeding Risk Score

HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (\>65 years), Drugs and Alcohol. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.

Time frame:
Baseline (Visit1)
Reported as:
Mean · unit on scale
Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score
unit on scaleCohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score1.8 ± 1.11.3 ± 0.91.1 ± 1.1
SecondaryPatient Characteristics at Baseline - Creatinine Clearance

Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.

Time frame:
Baseline (Visit1)
Reported as:
Mean · mL/min
Patient Characteristics at Baseline - Creatinine Clearance
mL/minCohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
Patient Characteristics at Baseline - Creatinine Clearance68.114 ± 23.14775.367 ± 29.02873.017 ± 29.179
PrimaryPatient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A

Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)

Time frame:
Baseline (Visit1)
Reported as:
Mean · Years
Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A
YearsCohort A (Switch Patients - Pradaxa)
Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A4.28 ± 3.63
SecondaryMean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment

Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 score.

Time frame:
Second assessment - Visit 2 (7-124 days after initiation on Pradaxa or VKA) and last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Reported as:
Mean · Unit on scale
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Unit on scaleCohort A (Switch Patients - Pradaxa)
Convenience dimension score (Visit 2)79.6 ± 18.1
Convenience dimension score (Visit 3)82.0 ± 16.8
Satisfaction dimension score (Visit 2)63.2 ± 14.6
Satisfaction dimension score (Visit 3)64.4 ± 14.7
Statistical analysis
  • Cohort A (Switch Patients - Pradaxa) · Paired t-test · p = 0.1234 (p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3))
  • Cohort A (Switch Patients - Pradaxa) · Paired t-test · p = 0.9740 (p-value of paired t-test compared between second assessment (Visit 2) and last assessment (Visit 3))
SecondaryDescription of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B

For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively. The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation. The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).

Time frame:
Baseline (Visit1)
Reported as:
Mean · Unit on scale
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B
Unit on scaleCohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
A1 - Confidence in prevention of blood clots3.4 ± 1.03.3 ± 1.0
A2 - Expectations of symptom relief3.4 ± 0.93.3 ± 1.0
A3 - Expectations of side effects2.5 ± 1.02.6 ± 1.0
A4 - Importance of ease of use3.7 ± 0.93.5 ± 1.0
A5 - Worries about making mistakes2.5 ± 1.22.5 ± 1.2
A6 - Importance of independency3.7 ± 0.93.7 ± 1.0
A7 - Worries about cost2.7 ± 1.22.6 ± 1.2

Adverse events

Collected over From the first administration of study medication until end of the study, up to 406 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort A (Switch Patients - Pradaxa)1/379 (0.3%)5/379 (1.3%)0/379 (0%)
Cohort B (New Patients - Pradaxa)0/591 (0%)1/591 (0.2%)0/591 (0%)
Cohort B (New Patients - VKA)0/343 (0%)6/343 (1.7%)0/343 (0%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventCohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)
International normalised ratio increasedInvestigations0/3790/5912/343
Acute myocardial infarctionCardiac disorders0/3790/5911/343
OverdoseInjury, poisoning and procedural complications0/3790/5911/343
Cerebral infarctionNervous system disorders0/3790/5911/343
HaematuriaRenal and urinary disorders0/3790/5911/343
Diverticulum intestinal haemorrhagicGastrointestinal disorders1/3790/5910/343
Gastrointestinal haemorrhageGastrointestinal disorders1/3790/5910/343
Lower gastrointestinal haemorrhageGastrointestinal disorders1/3790/5910/343
Upper gastrointestinal haemorrhageGastrointestinal disorders1/3790/5910/343
Multiple organ dysfunction syndromeGeneral disorders1/3790/5910/343

Baseline characteristics

The population consisted of all eligible patients (that is, all patients who took the prescribed treatment and without an important protocol violation) from all participating countries.

Age, Continuous
Age, Continuous(Years)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
Mean69.7 ± 9.067.3 ± 9.863.4 ± 10.967.0 ± 10.2
Age, Customized
Age, Customized(Participants)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
< 65 Years95196184475
>= 65 and < 75 Year154256101511
>= 75 Years13013958327
Sex: Female, Male
Sex: Female, Male(Participants)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
Female130228106464
Male249363237849
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
Count of participants———0
Region of Enrollment
Region of Enrollment(Participants)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
Korea, Republic Of — Non-South Korea5412432210
Korea, Republic Of — South Korea3254673111103
Type of hospital or practice
Type of hospital or practice(Participants)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
Public171255133559
Private200309201710
Other827944
Owner of medical practice
Owner of medical practice(Participants)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
Physician or physician group174268162604
Health Maintenance Organisation (HMO)0000
Community health center35210
Medical / academic health center156231144531
Other hospital224335100
Other health care corporation0000
Other2444068
Speciality of treating physician
Speciality of treating physician(Participants)Cohort A (Switch Patients - Pradaxa)Cohort B (New Patients - Pradaxa)Cohort B (New Patients - VKA)Total
Cardiologist3625723231257
General practitioner0314
Other specialist17161952

3 further baseline measures are reported on the registry.

08

Study locations

50 sites
  • Harapan Kita National Cardiovascular Center
    Jakarta Barat, 11420, Indonesia
  • Rumah Sakit Bina Waluya
    Jakarta Timur, 13750, Indonesia
  • Rumah Sakit Siloam Lippo Karawaci, Tangerang
    Tangerang, 15811, Indonesia
  • Korea University Ansan Hospital
    Ansan, 136-705, Korea, Republic of
  • Sejong General Hospital
    Bucheon, 422-711, Korea, Republic of
  • Inje University Busan Paik Hospital
    Busan, 47392, Korea, Republic of
  • Dong-A University Hospital
    Busan, 49201, Korea, Republic of
  • Pusan National Univ. Hosp
    Busan, 602-739, Korea, Republic of
  • Soon Chun Hyang University Hospital Cheonan
    Cheonan, 31151, Korea, Republic of
  • Dankook University Hospital
    Cheonan, 330-715, Korea, Republic of
  • Daegu Catholic University Medical Center
    Daegu, 42472, Korea, Republic of
  • Keimyung University Dongsan Medical Center
    Daegu, 700-712, Korea, Republic of
  • Kyungpook National Univ. Hosp
    Daegu, 700-721, Korea, Republic of
  • Yeungnam University Medical Center
    Daegu, 705-703, Korea, Republic of
  • Chungnam National University Hospital
    Daejoen, 301721, Korea, Republic of
  • Chonnam National University Hospital
    Gwangju, 501-757, Korea, Republic of
  • Chosun University Hospital
    Gwangju, 61453, Korea, Republic of
  • Wonkwang University School of Medicine &amp;amp; Hospital
    Iksan, 570-711, Korea, Republic of
  • Inha University Hospital
    Incheon, 400 711, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, 405-760, Korea, Republic of
  • Jeju National University Hospital
    Jeju, 690-767, Korea, Republic of
  • Chonbuk National University Hospital
    Jeonju, 561-712, Korea, Republic of
  • Gyeongsang National University Hospital
    Jinju, 660-702, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seongnam, 463-707, Korea, Republic of
  • The Catholic University of Korea, Seoul St.Mary's Hospital
    Seoul, 06591, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
  • Severance Hospital, Yonsei University Health System
    Seoul, 120-752, Korea, Republic of
  • VHS Medical Center
    Seoul, 134-791, Korea, Republic of
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
  • Gangnam Severance Hospital
    Seoul, 135-720, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, 136-705, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, 152-703, Korea, Republic of
  • Chung-Ang University Hospital
    Seoul, 156-755, Korea, Republic of
  • Ewha Womans University Mokdong Hospital
    Seoul, 158-710, Korea, Republic of
  • Ajou University Hospital
    Suwon, 443-380, Korea, Republic of
  • Wonju Severance Christian Hosp
    Wonju, 220-701, Korea, Republic of
  • Hospital Sultanah Bahiyah
    Alor Setar, 05460, Malaysia
  • Institut Jantung Negara
    Kuala Lumpur, 50400, Malaysia
  • Hospital University Kebangsaan Malaysia
    Kuala Lumpur, 56000, Malaysia
  • University Malaya Medical Centre
    Kuala Lumpur, 59100, Malaysia
  • Hospital Tengku Ampuan Afzan
    Kuantan, 25100, Malaysia
  • UiTM Sg Buloh Campus
    Sg Buloh, 47000, Malaysia
  • National Heart Center
    Singapore, 169609, Singapore
  • Changi General Hospital
    Singapore, 529889, Singapore
  • Bhumibol Adulyadej Hospital
    Bangkok, 10220, Thailand
  • King Chulalongkorn Hospital
    Bangkok, 10330, Thailand
  • Pramongkutklao Hospital
    Bangkok, 10400, Thailand
  • Ramathibodi Hospital
    Bangkok, 10400, Thailand
  • Chiangmai University
    Chiangmai, 50200, Thailand
  • Thammasat University Hospital
    Pathum Tani, 12120, Thailand
09

References and documents

Publications

  • Lee YS, Oh YS, Choi EK, Chern AKC, Jiampo P, Chutinet A, Hanafy DA, Trivedi P, Zhai D. Patient perception and treatment convenience of dabigatran versus vitamin K antagonist when used for stroke prophylaxis in atrial fibrillation: Real-world Evaluation of Long-term Anticoagulant Treatment Experience (RE-LATE) study. Open Heart. 2021 Dec;8(2):e001745. doi: 10.1136/openhrt-2021-001745. PubMed 34857666 ↗

Study documents

  • Statistical analysis plan · Jan 2, 2018
  • Study protocol · Jan 25, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02849509
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Jul 29, 2016
Start date
Jun 20, 2016
Primary completion
Dec 30, 2017
Completion
Dec 30, 2017
Results posted
Jul 8, 2019
Last update
Jul 8, 2019

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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