N/A
N=220
Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02022020 ↗Enrolled (actual)
220
Serious AEs
83.6%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge — 19.1; 76.8; 4.1 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge |
19.1; 76.8; 4.1 | — |
| PRIMARY Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge |
77.3; 13.6; 6.8; 9.5; 36.8; 71.4 | — |
| PRIMARY Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation |
73.2; 15.5; 45.9; 12.7; 28.6; 0.2 | — |
Summary
This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.
Eligibility Criteria
Inclusion criteria
- >=18 years of age;
- Confirmed diagnosis of Atrial Fibrillation (AF);
- Documentation that the patient had an acute GI and/or GU bleeding event and having taken at least one dose of dabigatran prior to the event.
Exclusion criteria
- Confirmed diagnosis of valvular AF (VAF);
- Documentation that the patient was taking dabigatran with other oral anticoagulant;
- Documentation of the patient receiving thrombolytic therapy prior to the event;
- Documentation that the patient was enrolled in an investigational clinical trial at the time of the event;
- Medical record was not available.
Data sourced from ClinicalTrials.gov (NCT02022020). 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.