Patient Convenience Study (RE-SONANCE)

NCT ID: NCT02684981

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9472 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-11
• Study Completion Date: 2017-06-01

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

Conditions

Atrial Fibrillation; Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A - VKA to Pradaxa switcher

Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.

No interventions assigned to this group

Cohort B - newly assigned to treatment

Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Multiple Locations, , Austria

Multiple Locations, , Bulgaria

Multiple Locations, , Czechia

Multiple Locations, , Estonia

Multiple Locations, , Hungary

Multiple Locations, , Israel

Multiple Locations, , Latvia

Multiple Locations, , Poland

Multiple Locations, , Romania

Multiple Locations, , Russia

Multiple Locations, , Serbia

Multiple Locations, , Slovenia

Countries

Austria; Bulgaria; Czechia; Estonia; Hungary; Israel; Latvia; Poland; Romania; Russia; Serbia; Slovenia

References

Vinereanu D, Napalkov D, Bergler-Klein J, Benczur B, Ciernik M, Gotcheva N, Medvedchikov A, Poder P, Simic D, Skride A, Tang W, Trusz-Gluza M, Vesely J. Patient perceptions of anticoagulant treatment with dabigatran or a vitamin K antagonist for stroke prevention in atrial fibrillation according to region and age: an exploratory analysis from the RE-SONANCE study. J Thromb Thrombolysis. 2021 Nov;52(4):1195-1206. doi: 10.1007/s11239-021-02450-2. Epub 2021 Apr 30.

Reference Type: DERIVED

PMID: 33929686 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

1160.249

Identifier Type: -

Identifier Source: org_study_id