Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lifelong oral anticoagulant (OAC) therapy is the preferred treatment for the prevention of thromboembolic events in the majority of patients with Atrial Fibrillation (AF). Adherence to medication is essential for valid treatment for OAC therapy.
The study aims to explore whether the advanced educational intervention would improve the adherence to dabigatran.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care (SOC) only | This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling. |
| |
| SOC with advanced educational intervention | This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral AntiCoagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dabigatran | Drug | Dabigatran |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention | Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | Number of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. |
Not provided
Inclusion Criteria:
Patients can be included if ALL the following criteria are met:
Exclusion Criteria:
Patients should not be included if ANY ONE of the following criteria is met:
Not provided
Not provided
Adult patients newly diagnosed with AF within 1 month, under 75 years old, and newly prescribed with dabigatran on physician's decision per local labelling will be equally randomized to receive standard of care (routine clinical practice) or standard of care (routine clinical practice) with advanced educational intervention.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chia-Yi Christian Hospital | Chia-Yi City | 40705 | Taiwan | |||
| Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41087222 | Derived | Chu CS, Tsai CT, Huang CY, Li CH, Tsai HL, Liu YB, Liu JC, Chang HR, Lin WS, Chao TF, Tsao TP, Shih JY, Chong JT, Huang SC, Wu CC, Lin CS, Shih CC, Cheng CI, Chao TH, Chiang CH, Huang CH, Chien CY, Lei WY, Lin KR, Chu PH, Lin TH. The RElationship of Advanced Education and ADherence (ReAHEAD) on antithrombotic in younger patients with non-valvular atrial fibrillation in Taiwan. J Formos Med Assoc. 2025 Oct 13:S0929-6646(25)00529-7. doi: 10.1016/j.jfma.2025.10.002. Online ahead of print. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Not provided
Not provided
Not provided
Not provided
Only participants that met all inclusion and none of the exclusion criteria were included. Participants were equally randomized in two cohorts: 'standard of care' and 'standard of care with advanced educational intervention'. Out of the 897 screened participants only 873 met the eligibility criteria and were included in the study.
A retrospective cohort data analysis was conducted to assess the impact of an advanced educational intervention on the adherence to dabigatran in newly diagnosed atrial fibrillation adult patients under 75 years old in Taiwan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SOC) Only | This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling. |
| FG001 | SOC With Advanced Educational Intervention |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Oct 21, 2020 | May 6, 2024 |
Not provided
Not provided
Not provided
Not provided
| at 3, 6, and 9 months |
| Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | Number of patients with medium adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A medium adherence was defined as achieving a MMAS-8 score of 6 or 7 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | At 3, 6, 9, and 12 months |
| Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | Number of patients with low adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A low adherence was defined as achieving a MMAS-8 score of 0, 1, 2, 3, 4, or 5 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | At 3, 6, 9, and 12 months |
| Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | Mean Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | At 3, 6, 9, and 12 months |
| Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention. | up to 12 months |
| Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention | Number of patients who discontinued treatment with dabigatran and reasons why they discontinued in patients with and without advanced educational intervention. | up to 12 months |
| Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Number of patients who switched treatment with dabigatran and reasons why they switched in patients with and without advanced educational intervention | up to 12 months |
| Chiayi City |
| 622 |
| Taiwan |
| National Taiwan University Hospital-Hsin-Chu Branch | Hsinchu | 300 | Taiwan |
| Buddhist Tzu Chi General Hospital | Hualien City | 970 | Taiwan |
| Kaohsiung Municipal Da-Tung Hospital | Kaohsiung City | 801 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| Taipei Medical University-Shuang Ho Hospital | New Taipei City | 235 | Taiwan |
| Pingtung Christian Hospital | Pingtung City | 900 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| Tungs' Taichung MetroHarbor Hospital | Taichung | 435 | Taiwan |
| Kuang-Tien General Hospital | Taichung | 437 | Taiwan |
| NCKUH | Tainan | 704 | Taiwan |
| Chi Mei Medical Center | Tainan | 71004 | Taiwan |
| National Taiwan University Hospital | Taipei | 10016 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Cathay General Hospital | Taipei | 106 | Taiwan |
| Taipei Medical University Hospital | Taipei | 110 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Cheng Hsin General Hospital | Taipei | 112 | Taiwan |
| Tri-Service General Hospital | Taipei | 11490 | Taiwan |
| Taipei Municipal Wanfang Hospital | Taipei | 11696 | Taiwan |
| Chang Gung Memorial Hospital(Linkou) | Taoyuan | 330 | Taiwan |
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. |
|
| 3 Months | Subjects who completed the 3 months visit. |
|
| 6 Months | Subjects who completed the 6 months visit. |
|
| 9 Months | Subjects who completed the 9 months visit. |
|
| 12 Months | Subjects who completed the 12 months visit. |
|
| COMPLETED | Subjects who completed the study completion visit. |
|
| NOT COMPLETED |
|
|
Cohort of newly diagnosed Atrial Fibrillation (AF) adult patients who were under 75 years old and were prescribed dabigatran.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SOC) Only | This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling. |
| BG001 | SOC With Advanced Educational Intervention | This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at Month 12 in Patients With and Without Advanced Educational Intervention | Number of patients with high adherence to dabigatran treatment at month 12 in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had high adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Count of Participants | Participants | at 12 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With High (MMAS-8 Score: 8 Points) Adherence to Dabigatran Treatment at 3, 6, and 9 Months in Patients With and Without Advanced Educational Intervention | Number of patients with high adherence to dabigatran treatment at 3, 6, and 9 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A high adherence was defined as achieving a MMAS-8 score of 8 Points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had high adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Count of Participants | Participants | at 3, 6, and 9 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Medium (MMAS-8 Score: 6 to 7 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | Number of patients with medium adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A medium adherence was defined as achieving a MMAS-8 score of 6 or 7 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had medium adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Count of Participants | Participants | At 3, 6, 9, and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Low (MMAS-8 Score: 0 to 5 Points) Adherence to Dabigatran Treatment at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | Number of patients with low adherence to dabigatran treatment at 3, 6, 9, and 12 months in patients with and without advanced educational intervention was assessed by the Morisky 8-Item Medication Adherence Questionnaire (MMAS-8). A low adherence was defined as achieving a MMAS-8 score of 0, 1, 2, 3, 4, or 5 points. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention who had low adherence to dabigatran. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Count of Participants | Participants | At 3, 6, 9, and 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean MMAS-8 Score at 3, 6, 9, and 12 Months in Patients With and Without Advanced Educational Intervention | Mean Morisky 8-Item Medication Adherence Questionnaire (MMAS-8) score at 3, 6, 9, and 12 months in patients with and without advanced educational intervention. The MMAS-8 is an 8-item structured, self-report measure that assesses medication adherence. The total score ranges from 0 to 8 with a higher score indicating a higher adherence. The validated Chinese MMAS-8 was used to evaluate the adherence to dabigatran at baseline and every follow-up visit. Patients were considered to have low adherence with scores of 0 to 5, medium adherence with scores of 6 to 7, and high adherence with a score of 8. | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Mean | Standard Deviation | Score on a scale | At 3, 6, 9, and 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Discontinued Treatment With Dabigatran in Patients With and Without Advanced Educational Intervention | Number of patients who discontinued treatment with dabigatran in patients with and without advanced educational intervention. | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Count of Participants | Participants | up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Discontinued Treatment With Dabigatran and Reasons Why They Discontinued in Patients With and Without Advanced Educational Intervention | Number of patients who discontinued treatment with dabigatran and reasons why they discontinued in patients with and without advanced educational intervention. | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Count of Participants | Participants | up to 12 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Switched Treatment With Dabigatran and Reasons Why They Switched in Patients With and Without Advanced Educational Intervention | Number of patients who switched treatment with dabigatran and reasons why they switched in patients with and without advanced educational intervention | Newly diagnosed Atrial Fibrillation (AF) patients who received dabigatran with and without advanced educational intervention and then switched treatment. Arms were mutually exclusive. Only patients with available data were included in this analysis. | Posted | Count of Participants | Participants | up to 12 months |
|
From baseline up to 12 months All cause mortality adverse events were collected also after the subjects withdrew from the study.
Subject who withdraw or discontinue the study due to adverse events which caused death and were reported in safety reports were also counted in All-Cause Mortality-Total Number Affected.
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 | Standard of Care (SOC) Only | This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling. | 3 | 441 | 4 | 441 | 0 | 441 |
| EG001 | SOC With Advanced Educational Intervention | This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. | 5 | 432 | 5 | 432 | 0 | 432 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Natural killer-cell lymphoblastic lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
|
Not provided
Document date is not required in the title page of the protocol/SEAP according to Boehringer Ingelheim internal policy.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 16, 2023 | May 6, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069604 | Dabigatran |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
|
|
|
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. |
|
|
|
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. |
|
|
|
This group includes Atrial Fibrillation (AF) patients diagnosed within 1 month, under 75 years old, and newly prescribed dabigatran on physician's decision based on local labelling who also received advance educational intervention. The educational intervention was based on material of the "Shared decision making of treatment of New Oral Anti Coagulants (NOAC) in AF patients" and "Atrial Fibrillation Patient Care in Hospitals". The educational materials were delivered after baseline and at their 3, 6, 9, and 12 months visit. |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|