Clinical trial NCT02849509: Patient Convenience Study- NIS RELATE
Official title: Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 1313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SEASK Patients with Non valvuar Atrial Fribrillation

Brief 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).


Eligibility criteria: 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:

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.

Primary outcomes:
measure: Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment
timeFrame: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
measure: Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment
timeFrame: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)
measure: Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups
timeFrame: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
measure: Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups
timeFrame: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
measure: Patient Characterization at Baseline - Categorical Parameters
timeFrame: Baseline (Visit1)
measure: Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A
timeFrame: Baseline (Visit1)
Secondary outcomes:
measure: Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score
timeFrame: Baseline (Visit1)
measure: Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score
timeFrame: Baseline (Visit1)
measure: Patient Characteristics at Baseline - Creatinine Clearance
timeFrame: Baseline (Visit1)
measure: Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
timeFrame: 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)
measure: Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B
timeFrame: Baseline (Visit1)
Other outcomes:
Locations:
city: Jakarta Barat
country: Indonesia
facility: Harapan Kita National Cardiovascular Center
city: Jakarta Timur
country: Indonesia
facility: Rumah Sakit Bina Waluya
city: Tangerang
country: Indonesia
facility: Rumah Sakit Siloam Lippo Karawaci, Tangerang
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National Univ. Hosp
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ. Hosp
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejoen
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University School of Medicine &amp;amp; Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hosp
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Kuala Lumpur
country: Malaysia
facility: Hospital University Kebangsaan Malaysia
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Sg Buloh
country: Malaysia
facility: UiTM Sg Buloh Campus
city: Singapore
country: Singapore
facility: National Heart Center
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Pramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chiangmai
country: Thailand
facility: Chiangmai University
city: Pathum Tani
country: Thailand
facility: Thammasat University Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.