Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 24 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: Pradaxa®
How many people: 1,315 participants
Where: 24 sitesTaiwan
Study dates: 20 Jun 2017to 11 Jan 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients 20 years of age or older with a diagnosis of non-valvular atrial fibrillation (NVAF).

Who may be able to join

Cohort A (patients switched from VKA to Pradaxa)
Written informed consent prior to participation.
Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF).
At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
Patients switched to Pradaxa prior to baseline assessment according to the physician's discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria.
OR Cohort B (patients newly initiated Pradaxa or VKA)

Show all 9Show fewer

Written informed consent prior to participation.
Female or male patients ≥ 20 years of age, newly diagnosed with NVAF, and no previous treatment for stroke prevention (no use of any OAC within 1 year prior to enrolment).
Patients initiated stroke prevention treatment with Pradaxa or VKA according to the physician's discretion and the SmPCs/reimbursement criteria.

Who cannot join

Contraindication to the use of Pradaxa® or VKA as described in the SmPCs.
Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF.
Current participation in any clinical trial of a drug or device.
Current participation in an AF-related registry, e.g. the Gloria AF program.

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Taiwan24 sites

Chang-Hua Christian Hospital
Changhua, 500
Show Chwan Memorial Hospital
Changhua
Chia-Yi Christian Hospital
Chia-Yi City, 40705
Hsinchu MacKay Memorial Hospital
Hsinchu
National Taiwan University Hospital-Hsin-Chu Branch
Hsinchu
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
E-Da Hospital
Kaohsiung City, 824
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Far Eastern Memorial Hospital
New Taipei City, 220
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
NCKUH
Tainan, 704
Chi Mei Medical Center
Tainan, 710
Tainan Municipal An-Nan Hospital
Tainan
National Taiwan University Hospital
Taipei, 10048
Mackay Memorial Hospital
Taipei, 10449
Taipei Medical University Hospital
Taipei, 110
Taipe Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 114
Shin Kong International HealthCare Center
Taipei
Taipei Municipal Wanfang Hospital
Taipei
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan, 330
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, 632

Other trials in Taiwan

About this study

Official title: Patients Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC)

Conditions: Atrial Fibrillation
Being tested: Pradaxa®
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pradaxa®Drug
Also called Dabigatran etexilate
Dabigatran etexilate

Study groups in NCT03187197
Study group	Role	What they receive
Cohort A		consented patients with NVAF in Taiwan with a previous VKA therapy, followed by switching to Pradaxa® Receives: Drug: Pradaxa®
Cohort B		patients being newly diagnosed with NVAF and initiated on Pradaxa® Receives: Drug: Pradaxa®

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
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).
Measured: Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
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.
Measured: Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).

Secondary outcomes (2)

Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
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).
Measured: Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).
Description of PACT-Q1 Items for Patients in Cohort B at 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).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201711 Jan 2019

First posted14 Jun 2017
Study start20 Jun 2017
Primary completion30 Jun 2018
Study completion11 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,315 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03187197
Sponsor's protocol ID: 1160-0286
Status last verified: Feb 2020
First submitted: 13 Jun 2017
Last updated: 24 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lee CW, Liu ME, Lee TM, Chang RY, Huang CY, Hu YF, Yeh HI. Patient satisfaction with dabigatrean and warfarin for stroke prevention in atrial fibrillation: Taiwan PASSION study. J Chin Med Assoc. 2021 Apr 1;84(4):375-382. doi: 10.1097/JCMA.0000000000000496.
PubMed 33784265

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patients Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC)
ClinicalTrials.gov ID: NCT03187197
Acronym / sponsor ID: 1160-0286
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 1,315 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Jun 2017 (actual)
Primary completion: 30 Jun 2018 (actual)
Study completion: 11 Jan 2019 (actual)
First posted: 14 Jun 2017 (actual)
Results: Posted 24 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cohort A	–	Drug: Pradaxa®consented patients with NVAF in Taiwan with a previous VKA therapy, followed by switching to Pradaxa®
Cohort B	–	Drug: Pradaxa®patients being newly diagnosed with NVAF and initiated on Pradaxa®

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients 20 years of age or older with a diagnosis of non-valvular atrial fibrillation (NVAF).

Key inclusion criteria (9 listed)

Cohort A (patients switched from VKA to Pradaxa)
Written informed consent prior to participation.
Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF).
At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
Patients switched to Pradaxa prior to baseline assessment according to the physician's discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria.

Key exclusion criteria (4 listed)

Contraindication to the use of Pradaxa® or VKA as described in the SmPCs.
Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF.
Current participation in any clinical trial of a drug or device.
Current participation in an AF-related registry, e.g. the Gloria AF program.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pradaxa®Also: Dabigatran etexilateDabigatran etexilate	Drug	Cohort A, Cohort B

Primary outcome

Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Time frame: 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).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Time frame: 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.

2 secondary outcomes

Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Time frame: Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Time frame: Baseline

Results and safety

Results posted to the registry on 24 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A	153	107
Cohort B - Pradaxa®	1,097	704
Cohort B - VKA	55	32

Primary outcome: Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment

Time frame: Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).. Mean (Standard Deviation). Unit: Units on Scale

Measure	Cohort A n = 139
Convenience - Baseline	86.9 (13.31)
Convenience - Visit 2	91.7 (10.74)
Convenience - Visit 3	95.2 (6.48)
Satisfaction - Baseline	64.3 (11.06)
Satisfaction - Visit 2	68.1 (13.36)
Satisfaction - Visit 3	72.5 (12.41)

Cohort A: p = 0.0001, Paired t-test
Cohort A: p = 0.0001, Paired t-test
Cohort A: p = 0.0031, Paired t-test

Population analysed: FAS

Primary outcome: Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups

Time frame: Visit 2 (30-45 days after initiation on Pradaxa® or VKA) and Visit 3 (150-210 days after initiation on Pradaxa® or VKA).. Mean (Standard Deviation). Unit: Units on Scale

Measure	Cohort B - Pradaxa® n = 1052	Cohort B - VKA n = 54
Pre-PSM Convenience - Visit 2	92.4 (9.88)	94.3 (5.61)
Pre-PSM Convenience - Visit 3	93.9 (8.41)	94.3 (6.35)
Pre-PSM Satisfaction - Visit 2	70.1 (11.51)	67.3 (9.17)
Pre-PSM Satisfaction - Visit 3	73.9 (12.05)	75.1 (11.95)
PSM Convenience - Visit 2	98.5 (2.18)	80.8 (9.79)
PSM Satisfaction - Visit 2	71.4 (0.00)	64.3 (2.02)

Cohort B - Pradaxa® vs Cohort B - VKA: p = 0.7879, t-test, 2 sided
Cohort B - Pradaxa® vs Cohort B - VKA: p = 0.6110, t-test, 2 sided
Cohort B - Pradaxa® vs Cohort B - VKA: p = 0.0832, t-test, 2 sided

Population analysed: FAS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent till end of the study; up to 210 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A	1 of 148 (0.7%)	0 of 148 (0%)	0 of 148
Cohort B - Pradaxa®	4 of 978 (0.4%)	0 of 978 (0%)	11 of 978
Cohort B - VKA	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33784265Lee CW, Liu ME, Lee TM, Chang RY, Huang CY, Hu YF, Yeh HI. Patient satisfaction with dabigatrean and warfarin for stroke prevention in atrial fibrillation: Taiwan PASSION study. J Chin Med Assoc. 2021 Apr 1;84(4):375-382. doi: 10.1097/JCMA.0000000000000496.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 24 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment (time frame: Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03187197, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2020.