N/A
N=1,305
Patients' Assessment of Satisfaction for Stroke Prevention in Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03187197 ↗Enrolled (actual)
1,305
Serious AEs
0.4%
Results posted
Feb 2020
Primary outcome: Primary: Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment — 86.9; 91.7; 95.2; 64.3 Units on Scale — p=0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pradaxa® (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment |
86.9; 91.7; 95.2; 64.3; 68.1; 72.5 | 0.0001 sig |
| PRIMARY Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups |
92.4; 94.3; 93.9; 94.3; 70.1; 67.3 | 0.7879 |
| SECONDARY Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment |
91.7; 95.2; 68.1; 72.5 | — |
| SECONDARY Description of PACT-Q1 Items for Patients in Cohort B at Baseline |
3.2; 3.0; 3.2; 3.1; 2.3; 2.1 | — |
Summary
To describe the treatment perception from patients with non-valvular atrial fibrillation (NVAF) receiving Pradaxa® or VKA for stroke prevention by using the self-estimation questionnaire of PACT-Q during a 6-month study period.
Eligibility Criteria
Inclusion criteria
Cohort A (patients switched from VKA to Pradaxa)
- Written informed consent prior to participation.
- Female or male patients ≥ 20 years of age with a diagnosis of non-valvular atrial fibrillation (NVAF).
- At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- Patients switched to Pradaxa prior to baseline assessment according to the physician's discretion and the Summary of Product Characteristics (SmPCs)/reimbursement criteria.
OR Cohort B (patients newly initiated Pradaxa or VKA)
- Written informed consent prior to participation.
- Female or male patients ≥ 20 years of age, newly diagnosed with NVAF, and no previous treatment for stroke prevention (no use of any OAC within 1 year prior to enrolment).
- Patients initiated stroke prevention treatment with Pradaxa or VKA according to the physician's discretion and the SmPCs/reimbursement criteria.
Exclusion criteria
- Contraindication to the use of Pradaxa® or VKA as described in the SmPCs.
- Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in NVAF.
- Current participation in any clinical trial of a drug or device.
- Current participation in an AF-related registry, e.g. the Gloria AF program.
Data sourced from ClinicalTrials.gov (NCT03187197). 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.