N/A
Completed N=1,489
This Study Uses the SITS Registry to Find Out When Patients With a Heart Rhythm Disorder (Atrial Fibrillation) Start Treatment With Dabigatran After They Had a Stroke
Source: ClinicalTrials.gov NCT03258645 ↗Enrolled (actual)
1,489
Serious AEs
—
Results posted
Jul 2020
Primary outcomePrimary: Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) — 5.9; 15.3; 27.7; 33.1 Percentage of participants
Summary
This is an observational study in patients with non-valvular atrial fibrillation (NVAF) presenting to the hospital with a first acute ischemic stroke based on existing data recorded in the SITS International Registry (located in Sweden) by physicians in several European countries, such as Italy, United Kingdom, Czech Republic, Sweden, Germany, Poland, Spain, Finland, Portugal, Slovakia, Denmark, Estonia, Norway Belgium, Hungary, Slovenia, Croatia, Austria, Lithuania, France, Greece, Netherlands, Ireland, Ukraine and Iceland.
The aim of this study is to explore the current real world use of dabigatran for stroke prevention in NVAF patients in the post-stroke setting. Secondary data from eligible European patients registered in the SITS registry will be considered; countries of origin are not known a priori.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Non-Valvular Atrial Fibrillation (NVAF) According to the Timing of Dabigatran Initiation After the First Ever Ischaemic Stroke (the Index Event) |
5.9; 15.3; 27.7; 33.1; 14.0; 4.0 | — |
| SECONDARY National Institute of Health Stroke Scale (NIHSS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period |
8; 8; 8; 12; 14; 15 | < 0.001 sig |
| SECONDARY Previous Modified Rankin Scale (mRS) at First Ever Ischaemic Stroke According to Dabigatran Initiation Time Period |
0; 0; 0; 0; 0; 0 | 0.01 sig |
| SECONDARY Age of Patients According to Dabigatran Initiation Time Period |
72; 74; 75; 75; 76; 77 | 0.016 sig |
| SECONDARY Diastolic Blood Pressure (DBP) of Patients According to Dabigatran Initiation Time Period |
87; 83; 84; 85; 85; 91 | 0.002 sig |
| SECONDARY CHA2DS2-VASc of Patients According to Dabigatran Initiation Time Period |
5; 5; 5; 5; 5; 5 | 0.04 sig |
| SECONDARY HAS-BLED of Patients According to Dabigatran Initiation Time Period |
3; 3; 3; 3; 3; 3 | 0.051 |
| SECONDARY Percentage of Patients With History of or Predisposition to Bleeding According to Dabigatran Initiation Time Period |
2.1; 1.1; 3.0; 3.0; 1.8; 4.4 | 0.026 sig |
| SECONDARY Number of Times of Reason to Delay Oral Anticoagulation (OAC) Entered by Physicians. |
40; 8; 61; 52; 14; 8 | — |
| SECONDARY Number of Times of Reason to Delay Dabigatran Initiation Entered by Physicians According to Dabigatran Initiation Time Period |
0; 0; 2; 2; 8; 1 | — |
| SECONDARY Number of Times of Reason to Chose Daily Dosage of 220 Milligram of Dabigatran Entered by Physicians |
6; 3; 18; 13; 8; 4 | — |
| SECONDARY Number of Times of Reason to Chose Daily Dosage of 300 Milligram of Dabigatran Entered by Physicians |
1; 38; 16; 18; 3; 10 | — |
Eligibility Criteria
Inclusion criteria
- Patients with non-valvular Atrial Fibrillation (NVAF)
- Patients presenting with their first acute ischemic stroke
- ≥18 years of age
Exclusion criteria
- Documentation that the patient was enrolled or is planned to be enrolled in an investigational clinical trial at the time of the onset of the index event and for the duration of the data collection
Data sourced from ClinicalTrials.gov (NCT03258645). 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.