Atrial FibrillationNCT02849509
Patient Convenience Study- NIS RELATE
An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 50 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Pradaxa (dabigatran) and Vitamin K antagonist
- How many people
- 1,313 participants
- Where
- 50 sitesin 5 countries
- Study dates
- 20 Jun 2016to 30 Dec 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SEASK Patients with Non valvuar Atrial Fribrillation
Who may be able to join
- Cohort A:
- A. Written informed consent prior to participation
- A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
- A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.
- OR
Show all 10Show fewer
- Cohort B:
- B. Written informed consent prior to participation.
- 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).
- B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.
Who cannot join
- Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
- Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
- Current participation in any clinical trial of a drug or device.
- Current participation in an European registry on the use of oral anticoagulation in AF.
Trial locations and contacts
50 sites in 5 countries.
50 sites in 5 countries
South Korea33 sites
Korea University Ansan Hospital
Ansan, 136-705
Sejong General Hospital
Bucheon-si, 422-711
Inje University Busan Paik Hospital
Busan, 47392
Dong-A University Hospital
Busan, 49201
Pusan National Univ. Hosp
Busan, 602-739
Soon Chun Hyang University Hospital Cheonan
Cheonan, 31151
Dankook University Hospital
Cheonan, 330-715
Daegu Catholic University Medical Center
Daegu, 42472
Keimyung University Dongsan Medical Center
Daegu, 700-712
Kyungpook National Univ. Hosp
Daegu, 700-721
Yeungnam University Medical Center
Daegu, 705-703
Chungnam National University Hospital
Daejoen, 301721
Chonnam National University Hospital
Gwangju, 501-757
Chosun University Hospital
Gwangju, 61453
Wonkwang University School of Medicine & Hospital
Iksan, 570-711
Inha University Hospital
Incheon, 400 711
Gachon University Gil Medical Center
Incheon, 405-760
Jeju National University Hospital
Jeju City, 690-767
Chonbuk National University Hospital
Jeonju, 561-712
Gyeongsang National University Hospital
Jinju, 660-702
Seoul National University Bundang Hospital
Seongnam, 463-707
The Catholic University of Korea, Seoul St.Mary's Hospital
Seoul, 06591
Seoul National University Hospital
Seoul, 110-744
Severance Hospital, Yonsei University Health System
Seoul, 120-752
VHS Medical Center
Seoul, 134-791
Samsung Medical Center
Seoul, 135-710
Gangnam Severance Hospital
Seoul, 135-720
Korea University Anam Hospital
Seoul, 136-705
Korea University Guro Hospital
Seoul, 152-703
Chung-Ang University Hospital
Seoul, 156-755
Ewha Womans University Mokdong Hospital
Seoul, 158-710
Ajou University Hospital
Suwon, 443-380
Wonju Severance Christian Hosp
Wŏnju, 220-701
Malaysia6 sites
Hospital Sultanah Bahiyah
Alor Star, 05460
Institut Jantung Negara
Kuala Lumpur, 50400
Hospital University Kebangsaan Malaysia
Kuala Lumpur, 56000
University Malaya Medical Centre
Kuala Lumpur, 59100
Hospital Tengku Ampuan Afzan
Kuantan, 25100
UiTM Sg Buloh Campus
Sg Buloh, 47000
Thailand6 sites
Bhumibol Adulyadej Hospital
Bangkok, 10220
King Chulalongkorn Hospital
Bangkok, 10330
Pramongkutklao Hospital
Bangkok, 10400
Ramathibodi Hospital
Bangkok, 10400
Chiangmai University
Chiang Mai, 50200
Thammasat University Hospital
Pathum Tani, 12120
Indonesia3 sites
Harapan Kita National Cardiovascular Center
Jakarta Barat, 11420
Rumah Sakit Bina Waluya
Jakarta Timur, 13750
Rumah Sakit Siloam Lippo Karawaci, Tangerang
Tangerang, 15811
Singapore2 sites
National Heart Center
Singapore, 169609
Changi General Hospital
Singapore, 529889
About this study
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.
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).
- Conditions
- Atrial Fibrillation
- Being tested
- Pradaxa (dabigatran), Vitamin K antagonist
- 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 (dabigatran)Drug
Pradaxa (dabigatran etexilate)110mg or 150mg
Vitamin K antagonistDrug
Vitamin K antagonist or Pradaxa
| Study group | Role | What they receive |
|---|---|---|
| Switch Patients / A | Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa. Receives: Drug: Pradaxa (dabigatran) | |
| New Patients / B | Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1). Receives: Drug: Vitamin K antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment
Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease \& treatment (2 items), \& anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience \& satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience \& for burden of disease and treatment were reversed (reversed score = 6 - item score), added together \& rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed \& rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable.
PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.
Measured: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment
Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable.
PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.
Measured: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups
Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.
Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.
PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.
Measured: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups
Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups.
Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome.
Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.
Measured: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Patient Characterization at Baseline - Categorical Parameters
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Measured: Baseline (Visit1)
Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A
Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)
Measured: Baseline (Visit1)
Secondary outcomes (5)
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Measured: Baseline (Visit1)
Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol.
HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
Measured: Baseline (Visit1)
Patient Characteristics at Baseline - Creatinine Clearance
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Measured: Baseline (Visit1)
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment.
The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items).
The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3)were compared with the second assessment (Visit 2). Within the PACT-Q2, 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 score.
Measured: 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)
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B
For Cohort B, scores of PACT-Q1 at baseline were summarised descriptively.
The PACT-Q1 is composed of a single dimension (7 items) covering the expectations of patients regarding their anticoagulant treatment and is to be administered before treatment initiation.
The PACT-Q1 scores ranged from 1 (Not at all) to 5 (Extremely/Completely/ Very much).
Measured: Baseline (Visit1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study start20 Jun 2016
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
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
- 1,313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849509
- Sponsor's protocol ID
- 1160.261
- Status last verified
- Apr 2019
- First submitted
- 4 May 2016
- Last updated
- 8 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 34857666
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02849509
- Acronym / sponsor ID
- 1160.261
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,313 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Posted 8 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switch Patients / A | – | Drug: Pradaxa (dabigatran)Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa. |
| New Patients / B | – | Drug: Vitamin K antagonistNewly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SEASK Patients with Non valvuar Atrial Fribrillation
Key inclusion criteria (10 listed)
- A. Written informed consent prior to participation
- A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
- A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.
- OR
Key exclusion criteria (4 listed)
- Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
- Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
- Current participation in any clinical trial of a drug or device.
- Current participation in an European registry on the use of oral anticoagulation in AF.
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 (dabigatran)Pradaxa (dabigatran etexilate)110mg or 150mg | Drug | Switch Patients / A |
| Vitamin K antagonistVitamin K antagonist or Pradaxa | Drug | New Patients / B |
Primary outcome
Mean Perception of Anticoagulant Treatment Questionnaire, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment
Time frame: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at second assessment compared to baseline assessment. The PACT-Q2 is composed of 3 dimensions covering: convenience (11 items), burden of disease \& treatment (2 items), \& anticoagulant treatment satisfaction (7 items). In this outcome the mean convenience \& satisfaction dimension scores of PACT-Q2 at second assessment (Visit 2) were compared with baseline assessment (Visit 1). Within the PACT-Q2, items for convenience \& for burden of disease and treatment were reversed (reversed score = 6 - item score), added together \& rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction were summed \& rescaled on 0-100 scale to determine satisfaction score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from analysis.
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Baseline Assessment
Time frame: Visit 1 (Baseline) and last assessment Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to baseline assessment. The mean convenience and satisfaction dimension scores of PACT-Q2 at the last assessment (Visit 3) were compared with the baseline assessment (Visit 1). Within the PACT-Q2, 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 score. High scores are more favorable. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second Assessment Compared Between Treatment Groups
Time frame: Second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the second assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement. PACT-Q2 which were completed more than 1 day after discontinuation of treatment or using incorrect procedure were excluded from the analysis.
Mean PACT-Q2 Scores, for Patients in Cohort B, at Last Assessment Compared Between Treatment Groups
Time frame: Last assessment - Visit 3 (125-365 days after initiation on Pradaxa or VKA)
Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups. Convenience dimension score and satisfaction dimension score of PACT-Q2 both range from 0 to 100 with high scores indicate better outcome. Mean PACT-Q2 scores, for patients in Cohort B, were compared between matched Pradaxa® and VKA patients at the last assessment. The mean convenience and satisfaction scores of PACT-Q2 were compared between matched Pradaxa® and VKA patients. Pradaxa® and VKA patients were matched based on propensity scores using a variable ratio, parallel, balanced 2:1, nearest neighbour matching algorithm with a caliper width of 0.05 and without replacement.
Patient Characterization at Baseline - Categorical Parameters
Time frame: Baseline (Visit1)
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Patient Characteristics at Baseline - Duration of Previous VKA Treatment for Cohort A
Time frame: Baseline (Visit1)
Duration of continuous VKA treatment for stroke prevention prior to baseline assessment (Cohort A)
5 secondary outcomes
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score
Time frame: Baseline (Visit1)
Patient Characteristics at Baseline - HAS-BLED Bleeding Risk Score
Time frame: Baseline (Visit1)
Patient Characteristics at Baseline - Creatinine Clearance
Time frame: Baseline (Visit1)
Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Time frame: 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)
Description of Perception of Anticoagulant Treatment Questionnaire, Part 1 (PACT-Q1) Items at Baseline for Cohort B
Time frame: Baseline (Visit1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34857666Lee 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.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
50 sites in 5 countries: 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 50 sites in 5 countries.
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 10 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 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in South Korea, Malaysia, Thailand, Indonesia, Singapore. 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 8 Jul 2019). 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, Part 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second Assessment Compared to Baseline Assessment (time frame: Visit 1 (Baseline) and second assessment Visit 2 (7-124 days after initiation on Pradaxa or VKA)). The study lists 6 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 NCT02849509, 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 8 Jul 2019.