Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
NCT ID: NCT03187197
Last Updated: 2020-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
1315 participants
OBSERVATIONAL
2017-06-20
2019-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
consented patients with NVAF in Taiwan with a previous VKA therapy, followed by switching to Pradaxa®
Pradaxa®
Dabigatran etexilate
Cohort B
patients being newly diagnosed with NVAF and initiated on Pradaxa®
Pradaxa®
Dabigatran etexilate
Interventions
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Pradaxa®
Dabigatran etexilate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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.
Exclusion Criteria
* 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.
20 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Chang-Hua Christian Hospital
Changhua, , Taiwan
Show Chwan Memorial Hospital
Changhua, , Taiwan
Chia-Yi Christian Hospital
Chia-Yi City, , Taiwan
Hsinchu MacKay Memorial Hospital
Hsinchu, , Taiwan
National Taiwan University Hospital-Hsin-Chu Branch
Hsinchu, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
E-Da Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
NCKUH
Tainan City, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
Tainan Municipal An-Nan Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipe Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Shin Kong International HealthCare Center
Taipei, , Taiwan
Taipei Municipal Wanfang Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan District, , Taiwan
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, , Taiwan
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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1160-0286
Identifier Type: -
Identifier Source: org_study_id
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