Clinical trial NCT03187197: Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
Official title: Patients Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation Impact of Conventional Oral Anticoagulant (OAC) Compared With Novel Oral Anticoagulant (NOAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-06-14
Enrollment: 1315
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 20 years of age or older with a diagnosis of non-valvular atrial fibrillation (NVAF).

Brief 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.


Eligibility criteria: Inclusion criteria:

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)

* 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:

* 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.

Primary outcomes:
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
timeFrame: Baseline, Visit 2 (30-45 days after initiation on Pradaxa®), Visit 3 (150-210 days after initiation on Pradaxa®).
measure: Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
timeFrame: 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:
measure: Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
timeFrame: Visit 2 (30-45 days after initiation on Pradaxa®) and Visit 3 (150-210 days after initiation on Pradaxa®).
measure: Description of PACT-Q1 Items for Patients in Cohort B at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Changhua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Changhua
country: Taiwan
facility: Show Chwan Memorial Hospital
city: Chia-Yi City
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Hsinchu
country: Taiwan
facility: Hsinchu MacKay Memorial Hospital
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital-Hsin-Chu Branch
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Kaohsiung
country: Taiwan
facility: E-Da Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: NCKUH
city: Tainan
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan
country: Taiwan
facility: Tainan Municipal An-Nan Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipe Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Shin Kong International HealthCare Center
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital(TaoYuan)
city: Yunlin County
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
References:
citation: 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.