Atrial Fibrillation
Conditions
Brief 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.
Detailed description
Purpose:
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days. | Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release. Emergency Department/Room (ED/ER). Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as: * Ongoing, if symptoms of bleeding not completely resolved at time of discharge; * Deceased in case of death; * Resolved otherwise. |
| Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. | Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible. |
| Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days. | Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible. |
Countries
Canada, United States
Participant flow
Recruitment details
This was an observational chart abstraction study.
Pre-assignment details
297 subjects were captured in the initial screening. 74 patients were deemed ineligible. A total of 3 patients were withdrawn after being included in the final study cohort following verification of ineligibility leaving 220 subjects eligible for study entry who were enrolled and included in the final study.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily). | 220 |
| Total | 220 |
Baseline characteristics
| Characteristic | Dabigatran (Pradax® in Canada; Pradaxa® in the United States) |
|---|---|
| Age, Continuous | 76.1 Years STANDARD_DEVIATION 10.3 |
| Gender Female | 108 Participants |
| Gender Male | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 79 / 220 |
| serious Total, serious adverse events | 184 / 220 |
Outcome results
Primary
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.
Time frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.
Population: Patients who received treatment at two countries (United States and Canada).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | GI Bleed | 73.2 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | Upper GI Bleed | 15.5 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | Lower GI Bleed | 45.9 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | GI Bleed - Location Unknown | 12.7 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | GU Bleed | 28.6 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation | Both GI and GU | 0.2 Percentage of participants |
Primary
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.
Time frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.
Population: Patients who received treatment at two countries (United States and Canada).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Any general intervention | 77.3 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Medications | 13.6 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Surgery | 6.8 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Therapeutic procedures | 9.5 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Transfusion/infusion | 36.8 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | Discontinuation of dabigatran | 71.4 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge | No interventions | 22.7 Percentage of participants |
Primary
Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge
Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release. Emergency Department/Room (ED/ER). Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as: * Ongoing, if symptoms of bleeding not completely resolved at time of discharge; * Deceased in case of death; * Resolved otherwise.
Time frame: From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.
Population: Patients who received treatment at two countries (United States and Canada).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge | Ongoing | 19.1 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge | Resolved | 76.8 Percentage of participants |
| Dabigatran (Pradax® in Canada; Pradaxa® in the United States) | Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge | Deceased | 4.1 Percentage of participants |