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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.
Study Design:
regulatory Post Marketed Surveillance study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pradaxa group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pradaxa (Dabigatran etexilate mesilate) | Drug | 110 mg or 150 mg b.i.d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 26 weeks |
| Percentage of Participants With Systemic Embolism |
Not provided
Inclusion criteria:
Exclusion criteria:
Patients with previous exposure to Pradaxa
Clinically significant bleeding
Increased risk of bleeding due to following diseases;
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
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Korean patients with non-valvular AF
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | South Korea |
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.
This study is a prospective, non-interventional, open-label, multi-centre study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analyses will be based on all patients treated, i.e. all patients who received at least one dose of Pradaxa.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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" | Safety analyses will be based on all patients treated, i.e. all patients who received at least one dose of Pradaxa. | Posted | Number | Adverse events | up to 26 weeks |
|
All adverse events occurring from the start of Pradaxa treatment up to 7 days after last follow-up visit; up to 26 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 10, 2013 | Feb 8, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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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. |
| up to 26 weeks |
| Violated inclusion/exclusion criteria |
|
| Follow-up failure |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | 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). | Posted | Number | percentage of participants | up to 26 weeks |
|
|
|
| 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. | Effectiveness Analysis set | Posted | Number | percentage of participants | up to 26 weeks |
|
|
|
| 5 |
| 3,053 |
| 104 |
| 3,053 |
| 0 |
| 3,053 |
| Gastritis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Brain stem infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Status epilepticus | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Mitral valve disease mixed | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Clonorchiasis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Encephalitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Arterial rupture | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Radiation proctitis | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Subarachnoid hemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Alcoholic liver disease | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|