N/A
Completed N=671
Treatment Convenience in Patients Treated With Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF)
Source: ClinicalTrials.gov NCT02839746 ↗Enrolled (actual)
671
Serious AEs
2.1%
Results posted
Nov 2019
Primary outcomePrimary: Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment — 59.86; 80.96; 49.15; 69.35 Units on Scale — p=<0.0001
Summary
Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Second Assessment Compared to Baseline Assessment |
59.86; 80.96; 49.15; 69.35 | <0.0001 sig |
| PRIMARY Mean of Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores at Last Assessment Compared to Baseline Assessment |
60.19; 84.29; 49.44; 73.19 | <0.0001 sig |
| PRIMARY Mean of Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) Score at Last Assessment Compared to Second Assessment |
80.95; 84.23; 69.54; 73.30 | <0.0001 sig |
| SECONDARY Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score |
3.60; 2.10 | — |
| SECONDARY Patient Characteristics at Baseline - Categorical Parameters |
132; 527; 88; 17; 159; 351 | — |
| SECONDARY Patient Characteristics at Baseline - Creatinine Clearance |
73.91 | — |
| SECONDARY Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration |
47.83 | — |
| SECONDARY Patient Characteristics at Baseline - Reasons for Switching From VKAs to Pradaxa® |
6; 6; 14; 29; 484; 45 | — |
| SECONDARY Reason for Changing the Dose of Pradaxa®: 150 mg/ Twice Daily (Bid) to 110 mg/Bid |
2; 1; 0; 2; 0; 3 | — |
| SECONDARY Reason for Changing the Dose of Pradaxa®: 110 mg/Bid to 150 mg/Bid |
0; 0; 0; 1; 0; 0 | — |
| SECONDARY Reasons for no Longer Receiving Pradaxa® Treatment |
8; 10; 1; 7; 7; 7 | — |
Eligibility Criteria
Inclusion criteria
- Written informed consent prior to participation
- Female and male patients 18 years of age or older with a diagnosis of non-valvular atrial fibrillation.
- At least 6 months of continuous vitamin K antagonist (VKA) treatment for stroke prevention prior to baseline assessment.
- Patients switched to Pradaxa® according to Summary of Product Characteristics, therapeutic positioning report from Spanish competent authorities and visa from each autonomous community.
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 non-valvular atrial fibrillation.
- Current participation in any clinical trial of a drug or device
Data sourced from ClinicalTrials.gov (NCT02839746). 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.