ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 23 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy. Read more about this study

Who is it for?: Ages 20 to 74 years
Conditions the study is for: Atrial Fibrillation
What is being tested?: Dabigatran
Type of treatment: Pill or oral medicine
How many people: 897 participants
Where: 23 sitesTaiwan
Study dates: 27 Aug 2020to 8 May 2023
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 20 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Adult patients newly diagnosed with AF within 1 month, under 75 years old, and newly prescribed with dabigatran on physician's decision per local labelling will be equally randomized to receive standard of care (routine clinical practice) or standard of care (routine clinical practice) with advanced educational intervention.

Who may be able to join

Patients can be included if ALL the following criteria are met:
Provide written informed consent prior to participation
Female or male adult patients aged ≥ 20 years and < 75 years, newly diagnosed with non-valvular atrial fibrillation (NVAF) within 1 month and has newly prescribed with dabigatran on physician's decision before study enrolment.

Who cannot join

Patients should not be included if ANY ONE of the following criteria is met:
Contraindication to the use of dabigatran (i.e., active pathological bleeding, history of a serious hypersensitivity reaction to dabigatran [e.g., anaphylactic reaction or anaphylactic shock], severely impaired renal function [Creatinine clearance rate (Ccr) < 30 mL/min], hemorrhagic manifestations, bleeding diathesis, mechanical prosthetic heart valve, congenital or acquired coagulation disorders, organic lesions with bleeding tendency, or concomitantly use systemic ketoconazole, cyclosporine, and itraconazole)
Participate in other interventional trials currently or in the past 30 days

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Taiwan23 sites

Chia-Yi Christian Hospital
Chia-Yi City, 40705
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Chiayi City, 622
National Taiwan University Hospital-Hsin-Chu Branch
Hsinchu, 300
Buddhist Tzu Chi General Hospital
Hualien City, 970
Kaohsiung Municipal Da-Tung Hospital
Kaohsiung City, 801
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
Pingtung Christian Hospital
Pingtung City, 900
Taichung Veterans General Hospital
Taichung, 40705
Tungs' Taichung MetroHarbor Hospital
Taichung, 435
Kuang-Tien General Hospital
Taichung, 437
NCKUH
Tainan, 704
Chi Mei Medical Center
Tainan, 71004
National Taiwan University Hospital
Taipei, 10016
Mackay Memorial Hospital
Taipei, 10449
Cathay General Hospital
Taipei, 106
Taipei Medical University Hospital
Taipei, 110
Taipei Veterans General Hospital
Taipei, 11217
Cheng Hsin General Hospital
Taipei, 112
Tri-Service General Hospital
Taipei, 11490
Taipei Municipal Wanfang Hospital
Taipei, 11696
Chang Gung Memorial Hospital(Linkou)
Taoyuan, 330

Other trials in Taiwan

About this study

Official title: Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients

The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.

Conditions: Atrial Fibrillation
Being tested: Dabigatran
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DabigatranDrug
Dabigatran

Study groups in NCT04532528
Study group	Role	What they receive
Standard of care (SOC) only		This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling. Receives: Drug: Dabigatran
SOC with advanced educational intervention		This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral AntiCoagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. Receives: Drug: Dabigatran

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention
Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points.
The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.
The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Measured: at 12 months

Secondary outcomes (7)

Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention
Number of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points.
The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.
The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Measured: at 3, 6, and 9 months
Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Number of patients with medium adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A medium adherence was defined as achieving a MMAS-8 score of 6 or 7 points.
The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.
The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Measured: At 3, 6, 9, and 12 months
Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Number of patients with low adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A low adherence was defined as achieving a MMAS-8 score of 0, 1, 2, 3, 4, or 5 points.
The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.
The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Measured: At 3, 6, 9, and 12 months
Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Mean Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention.
The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence.
The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.
Measured: At 3, 6, 9, and 12 months
Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention
Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention.
Measured: up to 12 months
Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention
Number of patients who discontinued treatment with dabigatran and reasons why they discontinued in patients with and without advanced educational intervention.
Measured: up to 12 months
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Number of patients who switched treatment with dabigatran and reasons why they switched in patients with and without advanced educational intervention
Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 20208 May 2023

First posted31 Aug 2020
Study start27 Aug 2020
Primary completion8 May 2023
Study completion8 May 2023

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: 897 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04532528
Sponsor's protocol ID: 1160-0304
Status last verified: May 2025
First submitted: 21 Aug 2020
Last updated: 15 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Publications

Chu CS, Tsai CT, Huang CY, Li CH, Tsai HL, Liu YB, Liu JC, Chang HR, Lin WS, Chao TF, Tsao TP, Shih JY, Chong JT, Huang SC, Wu CC, Lin CS, Shih CC, Cheng CI, Chao TH, Chiang CH, Huang CH, Chien CY, Lei WY, Lin KR, Chu PH, Lin TH. The RElationship of Advanced Education and ADherence (ReAHEAD) on antithrombotic in younger patients with non-valvular atrial fibrillation in Taiwan. J Formos Med Assoc. 2025 Oct 13:S0929-6646(25)00529-7. doi: 10.1016/j.jfma.2025.10.002. Online ahead of print.
PubMed 41087222

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients
ClinicalTrials.gov ID: NCT04532528
Acronym / sponsor ID: 1160-0304
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 897 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 27 Aug 2020 (actual)
Primary completion: 8 May 2023 (actual)
Study completion: 8 May 2023 (actual)
First posted: 31 Aug 2020 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Standard of care (SOC) only	–	Drug: DabigatranThis group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling.
SOC with advanced educational intervention	–	Drug: DabigatranThis group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral AntiCoagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit.

Who may qualify

Ages: 20 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult patients newly diagnosed with AF within 1 month, under 75 years old, and newly prescribed with dabigatran on physician's decision per local labelling will be equally randomized to receive standard of care (routine clinical practice) or standard of care (routine clinical practice) with advanced educational intervention.

Key inclusion criteria (3 listed)

Provide written informed consent prior to participation
Female or male adult patients aged ≥ 20 years and < 75 years, newly diagnosed with non-valvular atrial fibrillation (NVAF) within 1 month and has newly prescribed with dabigatran on physician's decision before study enrolment.

Key exclusion criteria (3 listed)

Contraindication to the use of dabigatran (i.e., active pathological bleeding, history of a serious hypersensitivity reaction to dabigatran [e.g., anaphylactic reaction or anaphylactic shock], severely impaired renal function [Creatinine clearance rate (Ccr) < 30 mL/min], hemorrhagic manifestations, bleeding diathesis, mechanical prosthetic heart valve, congenital or acquired coagulation disorders, organic lesions with bleeding tendency, or concomitantly use systemic ketoconazole, cyclosporine, and itraconazole)
Participate in other interventional trials currently or in the past 30 days

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
DabigatranDabigatran	Drug	SOC with advanced educational intervention, Standard of care (SOC) only

Primary outcome

Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention
Time frame: at 12 months
Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8.

7 secondary outcomes

Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention
Time frame: at 3, 6, and 9 months
Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Time frame: At 3, 6, 9, and 12 months
Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Time frame: At 3, 6, 9, and 12 months
Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
Time frame: At 3, 6, 9, and 12 months
Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention
Time frame: up to 12 months
Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention
Time frame: up to 12 months
Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
Time frame: up to 12 months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care (SOC) Only	441	269
SOC With Advanced Educational Intervention	432	243

Primary outcome: Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention

Time frame: at 12 months. Count of participants. Unit: Participants

Measure	Standard of Care (SOC) Only n = 271	SOC With Advanced Educational Intervention n = 246
Value	199	181

Standard of Care (SOC) Only vs SOC With Advanced Educational Intervention: p = 0.9701, Chi-squared

Population analysed: Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had high adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care (SOC) Only	4 of 441 (0.9%)	0 of 441 (0%)	3 of 441
SOC With Advanced Educational Intervention	5 of 432 (1.2%)	0 of 432 (0%)	5 of 432

Limitations and caveats (from the sponsor): Document date is not required in the title page of the protocol/SEAP according to Boehringer Ingelheim internal policy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41087222Chu CS, Tsai CT, Huang CY, Li CH, Tsai HL, Liu YB, Liu JC, Chang HR, Lin WS, Chao TF, Tsao TP, Shih JY, Chong JT, Huang SC, Wu CC, Lin CS, Shih CC, Cheng CI, Chao TH, Chiang CH, Huang CH, Chien CY, Lei WY, Lin KR, Chu PH, Lin TH. The RElationship of Advanced Education and ADherence (ReAHEAD) on antithrombotic in younger patients with non-valvular atrial fibrillation in Taiwan. J Formos Med Assoc. 2025 Oct 13:S0929-6646(25)00529-7. doi: 10.1016/j.jfma.2025.10.002. Online ahead of print.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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Active, not recruiting
ARIADNE Clinical Trial
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RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
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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.

The record lists no contact. Use the official record to reach the sponsor.

23 sites in 1 country: 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 23 sites in Taiwan.

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 3 inclusion and 3 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 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Taiwan. 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 19 Sep 2024). 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?

Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention (time frame: at 12 months). 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 NCT04532528, 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 15 May 2025.