Patient Convenience Study (RE-SONANCE)

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Boehringer Ingelheim

Status

Completed

Conditions

Atrial Fibrillation
Stroke

Study type

Observational

Funder types

Industry

Identifiers

NCT02684981
1160.249

Details and patient eligibility

About

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 milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

Enrollment

9,472 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cohort A:

  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

  1. Contraindication to the use of Pradaxa or VKA as described in the Summary of Product Characteristics (SmPC).
  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.

Trial design

9,472 participants in 2 patient groups

Cohort A - VKA to Pradaxa switcher
Description:
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
Cohort B - newly assigned to treatment
Description:
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

Trial documents
2

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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