Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran etexilate | Drug | 150 mg or 110 mg capsules twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy. | 12 month (Visit 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and > 2, respectively). | 6 month (visit 3) |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
AF patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Germany |
The patients were enrolled from 1000 sites from Germany. Approximately 2/3 (about 670) will be community-based primary care internists/general practitioners and approximately 1/3 (about 330) community-based cardiologists across Germany.
In this study 1506 patients were entered, 1421 patients had at least one documented prescription of dabigatran etexilate (DE) or vitamin K antagonists (VKA)and were analyzed in the Treated set. 952 patients were matched 1:1 based on Propensity Score (PS).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dabigatran (Dabigatran vs VKA) | Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention. |
| FG001 | Vitamin K Antagonists (VKA) | Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The Treated set (TS) includes all patients with main diagnosis of nonvalvular AF (=IC 2) with at least one evaluable efficacy endpoint (being on treatment is an efficacy endpoint).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dabigatran (Dabigatran vs VKA) | Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention. |
| BG001 | Vitamin K Antagonists (VKA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | TS |
| 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 | Percentage of Patients Treated With Anticoagulation Initially Started at the 12 Month | Percentage of patients treated with the initially allocated anticoagulant at the 12-month visit, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatran etexilate and VKA.Persistence is defined as the time between initiation and permanent discontinuation of therapy. The initiation date is the documented start of treatment (at visit 1), and the date of permanent discontinuation is the documented permanent discontinuation of dabigatran etexilate or VKA therapy. | Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 month (Visit 5) |
|
From start of treatment until six days after permanent treatment discontinuation or end of study, up to 12 months.
The Treated set (TS) includes all patients with main diagnosis of nonvalvular AF with at least one evaluable efficacy endpoint (being on treatment is an efficacy endpoint). Treatment emergent Adverse events were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dabigatran (Dabigatran vs VKA) | Patients with non-valvular AF treated with Dabigatran as the first Oral Anticoagulants (OACs) for stroke prevention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 4, 2016 | Dec 20, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2015 | Dec 20, 2018 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| C008208 | acarboxyprothrombin |
| D010644 | Phenprocoumon |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
| Vitamin K antagonists |
| Drug |
International Normalized Ratio (INR) 2-3 |
|
|
| Number of Patients With the Reason for Definitive Treatment Discontinuation | Number of patients with the reason for definitive treatment discontinuation | Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment) |
Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention.
| BG002 | Total | Total of all reporting groups |
| Full Range |
| Years |
|
| Sex: Female, Male | TS | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity was not reported in this trial | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Patients with non-valvular AF treated with dabigatran as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS).
| OG001 | VKA (Dabigatran vs VKA) | Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) were matched 1:1 based on Propensity Score (PS). |
|
|
|
| Secondary | Percentage of Patients With Low, Medium or High Adherence at the Timepoint of 6 Months-visit. | Percentage of patients with low, medium or high adherence at the 6-month visit, stratified for dabigatran etexilate and VKA; categorisation is done on the basis of the Morisky questionnaire (high, medium and low adherence with a Morisky score of 0, 1 to 2, and > 2, respectively). | Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA). | Posted | Number | Percentage of participants | 6 month (visit 3) |
|
|
|
| Secondary | Number of Patients With the Reason for Definitive Treatment Discontinuation | Number of patients with the reason for definitive treatment discontinuation | Patients in the TS who were matched 1:1 based on propensity score matching in order to ensure comparability of outcome variables between both treatment groups (dabigatran etexilate and VKA). | Posted | Count of Participants | Participants | Visit 2, 3, 4 and 5 (after approx. 3, 6, 9 and 12 months of treatment) |
|
|
|
| 10 |
| 771 |
| 45 |
| 771 |
| 0 |
| 771 |
| EG001 | Vitamin K Antagonists (VKA) | Patients with non-valvular AF treated with VKA as the first Oral Anticoagulants (OACs) for stroke prevention. | 5 | 650 | 39 | 650 | 0 | 650 |
| Atrial fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Mitral valve disease | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Optic ischaemic neuropathy | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oesophageal ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Large intestinal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Duodenal perforation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Papilla of Vater stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Biliary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Electrocardiogram change | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Troponin I increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral microangiopathy | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chorea | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral ischaemia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Mediastinal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | 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 |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| Male |
|
| High |
|
| Missing |
|
| Patient's wish |
|
| Decision of physician |
|
| Other |
|
| Visit 3 (Month 6) |
|
|
| Visit 4 (Month 9) |
|
|
| Visit 5 (Month 12) |
|
|