Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1313 participants
OBSERVATIONAL
2016-06-20
2017-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Patient Convenience Study (RE-SONANCE)
NCT02684981
Patient Convenience Study
NCT02597920
Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)
NCT02240667
Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist
NCT02687867
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
NCT02864758
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Switch Patients / A
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
Pradaxa (dabigatran)
Pradaxa (dabigatran etexilate)110mg or 150mg
New Patients / B
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
Vitamin K antagonist
Vitamin K antagonist or Pradaxa
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pradaxa (dabigatran)
Pradaxa (dabigatran etexilate)110mg or 150mg
Vitamin K antagonist
Vitamin K antagonist or Pradaxa
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Harapan Kita National Cardiovascular Center
Jakarta Barat, , Indonesia
Rumah Sakit Bina Waluya
Jakarta Timur, , Indonesia
Rumah Sakit Siloam Lippo Karawaci, Tangerang
Tangerang, , Indonesia
Hospital Sultanah Bahiyah
Alor Star, , Malaysia
Institut Jantung Negara
Kuala Lumpur, , Malaysia
Hospital University Kebangsaan Malaysia
Kuala Lumpur, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
UiTM Sg Buloh Campus
Sg Buloh, , Malaysia
National Heart Center
Singapore, , Singapore
Changi General Hospital
Singapore, , Singapore
Korea University Ansan Hospital
Ansan, , South Korea
Sejong General Hospital
Bucheon-si, , South Korea
Inje University Busan Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Pusan National Univ. Hosp
Busan, , South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, , South Korea
Dankook University Hospital
Cheonan, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Kyungpook National Univ. Hosp
Daegu, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
Chungnam National University Hospital
Daejoen, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Wonkwang University School of Medicine & Hospital
Iksan, , South Korea
Inha University Hospital
Incheon, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
VHS Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Wonju Severance Christian Hosp
Wŏnju, , South Korea
Bhumibol Adulyadej Hospital
Bangkok, , Thailand
King Chulalongkorn Hospital
Bangkok, , Thailand
Pramongkutklao Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Chiangmai University
Chiang Mai, , Thailand
Thammasat University Hospital
Pathum Tani, , Thailand
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1160.261
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.