N/A
Completed N=9,465
Patient Convenience Study (RE-SONANCE)
Source: ClinicalTrials.gov NCT02684981 ↗Enrolled (actual)
9,465
Serious AEs
0.7%
Results posted
Jul 2019
Primary outcomePrimary: Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment — 19.23; 23.08 Unit on scale — p=< 0.0001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment |
19.23; 23.08 | < 0.0001 sig |
| PRIMARY Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment |
17.86; 21.43 | < 0.0001 sig |
| PRIMARY Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups |
82.69; 50.00; 86.54; 59.62 | < 0.001 sig |
| PRIMARY Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups |
67.86; 50.00; 71.43; 50.00 | < 0.001 sig |
| PRIMARY 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 |
88.3; 87.8; 91.4; 5.4; 8.2; 7.0 | — |
| PRIMARY 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 |
59.2; 29.1; 31.3; 31.0; 64.8; 65.7 | — |
| PRIMARY Characterization of Patients With Respect to Kidney Function (Creatinine Clearance) |
73.89; 76.24; 71.83; 74.59; 75.27; 71.86 | — |
| PRIMARY Characterization of Patients With Respect to Comorbidities |
86.4; 83.4; 90.9 | — |
| PRIMARY Characterization of Patients With Respect to Concomitant Therapies |
86.4; 83.4; 91.2 | — |
| PRIMARY Characterization of Patients With Respect to Dosing of Pradaxa |
34.9; 30.4; 65.1; 69.6 | — |
| PRIMARY Duration in Months of Previous VKA Treatment |
34.00 | — |
| PRIMARY Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable) |
— | — |
| SECONDARY PACT-Q2 Scores at Last Assessment Compared to Second Assessment |
1.92; 3.57 | < 0.001 sig |
| SECONDARY Description of PACT-Q1 Items at Baseline |
2.2; 2.4; 2.0; 3.1; 9.6; 13.0 | — |
Eligibility Criteria
Inclusion criteria
Cohort A:
- A. Written informed consent prior to participation
- A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
- A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- A. Patients switched to Pradaxa according Summary of Product Characteristics and physician's discretion.
OR
Cohort B:
- B. Written informed consent prior to participation.
- 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).
- B. Stroke prevention treatment initiated with Pradaxa or VKA according to Summary of Product Characteristics and physician's discretion.
Exclusion criteria
- Contraindication to the use of Pradaxa or VKA as described in the Summary of Product Characteristics (SmPC).
- Patients receiving Pradaxa or VKA for any other condition than stroke prevention in atrial fibrillation.
- Current participation in any clinical trial of a drug or device.
- Current participation in an European registry on the use of oral anticoagulation in AF.
Data sourced from ClinicalTrials.gov (NCT02684981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.