Clinical trial NCT04532528: ReAHEAD: A Study to Find Out Whether Education Improves Adherence to Dabigatran in People With Atrial Fibrillation Who Are Younger Than 75 Years
Official title: Relationship of Advanced Holding Education and ADherence on Antithrombotic in Younger SPAF Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 897
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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


Eligibility criteria: Inclusion Criteria:

Patients can be included if ALL the following criteria are met:

1. Provide written informed consent prior to participation
2. 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.

Exclusion Criteria:

Patients should not be included if ANY ONE of the following criteria is met:

1. 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)
2. Participate in other interventional trials currently or in the past 30 days

Primary outcomes:
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
timeFrame: at 12 months
Secondary outcomes:
measure: 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
timeFrame: at 3, 6, and 9 months
measure: 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
timeFrame: At 3, 6, 9, and 12 months
measure: 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
timeFrame: At 3, 6, 9, and 12 months
measure: Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention
timeFrame: At 3, 6, 9, and 12 months
measure: Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention
timeFrame: up to 12 months
measure: Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention
timeFrame: up to 12 months
measure: Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Chia-Yi City
country: Taiwan
facility: Chia-Yi Christian Hospital
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital-Hsin-Chu Branch
city: Hualien
country: Taiwan
facility: Buddhist Tzu Chi General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Municipal Da-Tung Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Pingtung
country: Taiwan
facility: Pingtung Christian Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Tungs' Taichung MetroHarbor Hospital
city: Taichung
country: Taiwan
facility: Kuang-Tien General Hospital
city: Tainan,
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan
country: Taiwan
facility: NCKUH
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital(Linkou)
Study officials:
References: