Atrial Fibrillation
Conditions
Brief summary
This is a prospective, non-interventional, open-label, multi-centre study. It will provide additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical settings.
Detailed description
Study Design: regulatory Post Marketed Surveillance study
Interventions
DRUGPradaxa (Dabigatran etexilate mesilate)
110 mg or 150 mg b.i.d.
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 18 years at enrollment * Patients who have been started on Pradaxa in accordance with the approved label in Korea * Patients who have signed on the data release consent form
Exclusion criteria
* Patients with previous exposure to Pradaxa * Clinically significant bleeding * Increased risk of bleeding due to following diseases; * Recent gastrointestinal ulceration * Recent intracranial or intracerebral bleeding history * Intraspinal or intracerebral vascular abnormalities * Recent brain, spinal or ophthalmic surgery * Recent brain or spinal injury * Known or suspected oesophageal varices * Arteriovenous malformations * Vascular aneurysms * Presence of malignant neoplasms at high risk of bleeding * Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessary to maintain an open central venous or arterial catheter * Severe renal impairment (CrCl \< 30mL/min) * Concomitant treatment with oral ketoconazole or dronedarone * Patients hypersensitive to dabigatran or dabigatran etexilate or to any ingredient in the formulation * Prosthetic heart valve replacement * No creatinine clearance collected within at least one year prior to enrollment * Current participation in other clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality) | up to 26 weeks | Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality). Number analyzed presents the Number of participants with Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Stroke | up to 26 weeks | Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction. |
| Percentage of Participants With Systemic Embolism | up to 26 weeks | Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy. |
Countries
South Korea
Participant flow
Recruitment details
This study is a prospective, non-interventional, open-label, multi-centre study.
Pre-assignment details
All subjects were screened for eligibility to participate in the trial. Subjects attended a specialist sites which ensured that they met all strictly implemented inclusion/exclusion criteria. Subjects were not to be entered to trial treatment if any one of the specific entry criteria was violated.
Participants by arm
| Arm | Count |
|---|---|
| Pradaxa Group Physician carefully reviewed the special precautions for use in patients with risk of bleeding before determining the dose of Pradaxa and patients were prescribed dabigatran dose for 24±2 weeks from the options described below:
* Dabigatran etexilate mesilate 110 mg b.i.d. (oral administration of one capsule twice daily )
* Dabigatran etexilate mesilate 150 mg b.i.d. (oral administration of one capsule twice daily) | 3,053 |
| Total | 3,053 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administered prior to the contract date | 4 |
| Overall Study | Follow-up failure | 34 |
| Overall Study | Never taken the PRADAXA during the study | 4 |
| Overall Study | Subjects of contraindications | 34 |
| Overall Study | Violated inclusion/exclusion criteria | 53 |
Baseline characteristics
| Characteristic | Pradaxa Group | — |
|---|---|---|
| Age, Continuous | 70.26 years STANDARD_DEVIATION 9.64 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1201 Participants | — |
| Sex: Female, Male Male | 1852 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 3,053 |
| other Total, other adverse events | 0 / 3,053 |
| serious Total, serious adverse events | 104 / 3,053 |
Outcome results
Primary
Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality)
Occurrence of adverse events(Including unexpected adverse events, serious adverse events, drug-related adverse events, adverse events leading to discontinuation and adverse events by intensity, outcome of the event, causality). Number analyzed presents the Number of participants with Adverse events
Time frame: up to 26 weeks
Population: Safety analyses will be based on all patients treated, i.e. all patients who received at least one dose of Pradaxa.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pradaxa Group | Occurrence of Adverse Events(Including Unexpected Adverse Events, Serious Adverse Events, Drug-related Adverse Events, Adverse Events Leading to Discontinuation and Adverse Events by Intensity, Outcome of the Event, Causality) | 871 Adverse events |
Secondary
Percentage of Participants With Stroke
Stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of haemorrhage or infarction.
Time frame: up to 26 weeks
Population: Effectiveness Analysis set: Effectiveness analysis will be performed to the patients who have been on Pradaxa more than 12 weeks (in case of long-term follow up, 24 weeks).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pradaxa Group | Percentage of Participants With Stroke | No | 99.70 percentage of participants |
| Pradaxa Group | Percentage of Participants With Stroke | Yes | 0.30 percentage of participants |
Secondary
Percentage of Participants With Systemic Embolism
Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.
Time frame: up to 26 weeks
Population: Effectiveness Analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pradaxa Group | Percentage of Participants With Systemic Embolism | No | 100.0 percentage of participants |
| Unknown | Percentage of Participants With Systemic Embolism | Yes | — percentage of participants |