Clinical trial NCT02684981: Patient Convenience Study (RE-SONANCE)
Official title: Non-interventional Study Describing Patients´ Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 9472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: European patients with non valvular atrial fibrillation

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).


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.

Primary outcomes:
measure: Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
timeFrame: From baseline up to 210 days
measure: Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
timeFrame: From baseline up to 210 days
measure: Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
timeFrame: Day 30 up to Day 210
measure: Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
timeFrame: Day 30 up to Day 210
measure: Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
timeFrame: Baseline
measure: Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
timeFrame: Baseline
measure: Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
timeFrame: Baseline and up to 210 days
measure: Characterization of Patients With Respect to Comorbidities
timeFrame: Baseline
measure: Characterization of Patients With Respect to Concomitant Therapies
timeFrame: Baseline
measure: Characterization of Patients With Respect to Dosing of Pradaxa
timeFrame: Baseline and up to 210 days
measure: Duration in Months of Previous VKA Treatment
timeFrame: Baseline
measure: Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable)
timeFrame: Baseline
Secondary outcomes:
measure: PACT-Q2 Scores at Last Assessment Compared to Second Assessment
timeFrame: From 30 days up to 210 days
measure: Description of PACT-Q1 Items at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Multiple Locations
country: Austria
city: Multiple Locations
country: Bulgaria
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Estonia
city: Multiple Locations
country: Hungary
city: Multiple Locations
country: Israel
city: Multiple Locations
country: Latvia
city: Multiple Locations
country: Poland
city: Multiple Locations
country: Romania
city: Multiple Locations
country: Russian Federation
city: Multiple Locations
country: Serbia
city: Multiple Locations
country: Slovenia
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.