Thromboembolism, Heart Valve Prosthesis
Conditions
Brief summary
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
Interventions
active treatment (low)
DRUGwarfarin 5mg
comparator warfarin
active treatment (medium)
DRUGwarfarin 1mg
comparator warfarin
active treatment (high)
DRUGwarfarin 3mg
comparator warfarin
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Completed study 1160.113 per protocol 2. Continuing need for anticoagulation
Exclusion criteria
1. uncontrolled hypertension 2. severe renal impairment 3. active liver disease 4. increased risk of bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Any Adverse Event (AE) | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With AEs Leading to Discontinuation of Trial Drug | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events. |
| Percentage of Patients With Serious AEs | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events. |
| Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days) | Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis |
Countries
Belgium, Canada, Czechia, Denmark, France, Germany, Netherlands, Norway, Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Etexilate (DE) Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily | 99 |
| Warfarin Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator | 59 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Dabigatran Etexilate (DE) | Warfarin | Total |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 8 | 56.1 years STANDARD_DEVIATION 10.1 | 57.2 years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 37 Participants | 19 Participants | 56 Participants |
| Sex: Female, Male Male | 62 Participants | 40 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 99 | 4 / 59 |
| serious Total, serious adverse events | 3 / 99 | 4 / 59 |
Outcome results
Primary
Percentage of Patients With Any Adverse Event (AE)
Percentage of patients with Adverse Events. Prespecified clinical outcome events were not recorded as Adverse Events.
Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate (DE) | Percentage of Patients With Any Adverse Event (AE) | 39.4 percentage of participants |
| Warfarin | Percentage of Patients With Any Adverse Event (AE) | 37.3 percentage of participants |
Secondary
Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis.
Clinical efficacy outcome events presented are: Death, Venous thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attack (TIA), Stroke, Systemic embolism and Valve thrombosis
Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate (DE) | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Myocardial Infarction | 1.0 percentage of participants |
| Dabigatran Etexilate (DE) | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Stroke | 3.0 percentage of participants |
| Dabigatran Etexilate (DE) | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Venous thromboembolism | 0.0 percentage of participants |
| Dabigatran Etexilate (DE) | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Systemic embolism | 0.0 percentage of participants |
| Dabigatran Etexilate (DE) | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Transient Ischaemic Attack | 1.0 percentage of participants |
| Dabigatran Etexilate (DE) | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Valve thrombosis | 2.0 percentage of participants |
| Dabigatran Etexilate (DE) | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Death | 0.0 percentage of participants |
| Warfarin | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Valve thrombosis | 0.0 percentage of participants |
| Warfarin | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Death | 1.7 percentage of participants |
| Warfarin | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Venous thromboembolism | 0.0 percentage of participants |
| Warfarin | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Myocardial Infarction | 0.0 percentage of participants |
| Warfarin | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Transient Ischaemic Attack | 0.0 percentage of participants |
| Warfarin | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Stroke | 0.0 percentage of participants |
| Warfarin | Percentage of Deaths, Venous Thromboembolism (VTE), Myocardial Infarction (MI), Transient Ischaemic Attacks (TIA), Strokes, Systemic Embolism, and Valve Thrombosis. | Systemic embolism | 0.0 percentage of participants |
Secondary
Percentage of Patients With AEs Leading to Discontinuation of Trial Drug
Percentage of patients with Adverse Events leading to discontinuation of trial drug. Prespecified clinical outcome events were not recorded as Adverse Events.
Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate (DE) | Percentage of Patients With AEs Leading to Discontinuation of Trial Drug | 5.1 percentage of participants |
| Warfarin | Percentage of Patients With AEs Leading to Discontinuation of Trial Drug | 1.7 percentage of participants |
Secondary
Percentage of Patients With Serious AEs
Percentage of patients with Serious Adverse Events (SAE). Prespecified clinical outcome events were not recorded as Adverse Events.
Time frame: From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days)
Population: Treated set (TRT): The TRT comprised all patients who were documented to have taken at least 1 dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dabigatran Etexilate (DE) | Percentage of Patients With Serious AEs | 3.0 percentage of participants |
| Warfarin | Percentage of Patients With Serious AEs | 6.8 percentage of participants |