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

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Boehringer Ingelheim

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Drug: Dabigatran

Study type

Observational

Funder types

Industry

Identifiers

NCT04532528
1160-0304

Details and patient eligibility

About

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.

Enrollment

898 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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 design

898 participants in 2 patient groups

Patients receiving standard of care (SOC)
Description:
(without advanced educational Intervention)
Treatment:
Drug: Dabigatran
Patients receiving SOC with advanced educational intervention
Treatment:
Drug: Dabigatran

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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