Atrial Fibrillation, Percutaneous Coronary Intervention
Conditions
Brief summary
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome). The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.
Interventions
Active treatment
DRUGWarfarin 3mg
Active comparator
DRUGAspirin
Active comparator
Active treatment
DRUGClopidogrel or Ticagrelor
Active comparator
DRUGWarfarin 5mg
Active comparator
DRUGWarfarin 1mg
Active comparator
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged \>=18 years * Patients with Non Valvular Atrial Fibrillation * Patient presenting with: An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI \[NSTEMI\] or unstable angina \[UA\]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES) * The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.
Exclusion criteria
* Patients with a mechanical or biological heart valve prosthesis * Cardiogenic shock during current hospitalisation * Stroke within 1 month prior to screening visit * Patients who have had major surgery within the month prior to screening * Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated * Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit * Anaemia (haemoglobin \<10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count \<100 x 109/L) at screening * Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) \<30mL/min at screening * Active liver disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Adjudicated ISTH MBE or CRNMBE | up to 30 months | Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Adjudicated Non-CV | up to 30 months | Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported. Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV |
| Time to Adjudicated CV | up to 30 months | Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported. CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes. |
| Time to Adjudicated All Cause Death | up to 30 months | Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death. |
| Time to First Adjudicated MI | up to 30 months | Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported |
| Time to First Adjudicated Stroke | up to 30 months | Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported. 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 to Adjudicated Undetermined Cause of Death | up to 30 months | Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported. This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was patient died) or when there was insufficient supporting information or detail to assign the cause of death. |
| Time to First Adjudicated ST | up to 30 months | Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported. |
| Time to Composite Endpoint of Death + MI + Stroke | up to 30 months | Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported. |
| Time to Composite Endpoint of Death or First Thrombotic Event | up to 30 months | Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE). |
| Time to First Adjudicated Unplanned Revascularisation by PCI/CABG | up to 30 months | Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported. |
| Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG | up to 30 months | Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported. |
| Time to First Adjudicated SE | up to 30 months | Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported. SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Patients aged ≥80 years in the United States of America (USA) were assigned to 110 milligram (mg) Dual antithrombotic therapy with dabigatran etexilate (DE-DAT), 150 mg DE-DAT, or warfarin. All other patients including aged ≥80 years (for Japan ≥70 years) outside of the USA were assigned to 110 mg DE-DAT or warfarin
Pre-assignment details
All patients (Pts) were screened for eligibility to participate in trial. Pts attended sites to ensure that they met all implemented inclusion/exclusion criteria. Pts were not to be randomised to trial drug if any of specific entry criteria was violated. In this study, 2725 Pts were entered & randomised. 2678 Pts were treated.
Participants by arm
| Arm | Count |
|---|---|
| Dabigatran Etexilate 110mg Patients were orally administered Dabigatran Etexilate 110mg capsule twice daily (BID) for at least 6 months. | 981 |
| Dabigatran Etexilate 150mg Patients were orally administered Dabigatran Etexilate 150mg capsule twice daily (BID) for at least 6 months. | 763 |
| Warfarin Patients were orally administered warfarin 1 mg, 3 mg, or 5 mg tablets once daily for at least 6 months. The warfarin dose was titrated as needed to maintain the target International normalised ratio (INR) of 2.0 to 3.0 (2.0 to 2.6 for Japanese patients aged ≥70 years); 2.0 to 2.5 if feasible | 981 |
| Total | 2,725 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Consent withdrawn, not due to AE | 21 | 8 | 56 |
| Overall Study | Lost to Follow-up | 4 | 3 | 2 |
| Overall Study | Other Adverse Event (AE) | 52 | 32 | 49 |
| Overall Study | Other pre-existing disease worsening | 6 | 4 | 9 |
| Overall Study | Other than stated | 3 | 4 | 14 |
| Overall Study | Protocol Violation | 2 | 4 | 1 |
| Overall Study | Trial disease worsening | 7 | 5 | 1 |
Baseline characteristics
| Characteristic | Total | Dabigatran Etexilate 110mg | Dabigatran Etexilate 150mg | Warfarin |
|---|---|---|---|---|
| Age, Continuous | 70.8 Years STANDARD_DEVIATION 8.66 | 71.5 Years STANDARD_DEVIATION 8.87 | 68.6 Years STANDARD_DEVIATION 7.65 | 71.7 Years STANDARD_DEVIATION 8.9 |
| Age, Customized <80: EU/ROW | 2142 Participants | 725 Participants | 699 Participants | 718 Participants |
| Age, Customized ≥80: EU/ROW | 384 Participants | 189 Participants | 3 Participants | 192 Participants |
| Age, Customized <80: USA | 168 Participants | 54 Participants | 53 Participants | 61 Participants |
| Age, Customized ≥80: USA | 31 Participants | 13 Participants | 8 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 175 Participants | 70 Participants | 46 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2507 Participants | 903 Participants | 700 Participants | 904 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 43 Participants | 8 Participants | 17 Participants | 18 Participants |
| Race/Ethnicity, Customized Asian | 320 Participants | 116 Participants | 79 Participants | 125 Participants |
| Race/Ethnicity, Customized Black | 15 Participants | 5 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Missing | 26 Participants | 4 Participants | 11 Participants | 11 Participants |
| Race/Ethnicity, Customized Other | 20 Participants | 5 Participants | 8 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 2344 Participants | 851 Participants | 658 Participants | 835 Participants |
| Sex: Female, Male Female | 655 Participants | 253 Participants | 171 Participants | 231 Participants |
| Sex: Female, Male Male | 2070 Participants | 728 Participants | 592 Participants | 750 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 38 / 972 | 24 / 758 | 41 / 948 |
| other Total, other adverse events | 128 / 972 | 126 / 758 | 229 / 948 |
| serious Total, serious adverse events | 415 / 972 | 300 / 758 | 396 / 948 |
Outcome results
Primary
Time to First Adjudicated ISTH MBE or CRNMBE
Time to event analysis of patients with first adjudicated International Society of Thrombosis and Haemostasis (ISTH) Major Bleeding Event (MBE) or Clinically Relevant Non Major Bleeding Event (CRNMBE). The number of observed patients with adjudicated ISTH MBE or CRNMBE was reported. Full analysis set (FAS): All consenting patients randomised were analysed in the treatment group to which they were randomised regardless of whether they took trial medication. The start date of the observation period for this analysis set was the date of randomisation. Patients who discontinued trial medication were followed until the end of the trial. Patients who were lost to follow-up for vital status were censored for the primary endpoint at the time of their last known vital status. Intention to treat period: The observation period for these analysis was the so called 'intention to treat period'.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to First Adjudicated ISTH MBE or CRNMBE | 151 Participants |
| Dabigatran Etexilate 150mg | Time to First Adjudicated ISTH MBE or CRNMBE | 154 Participants |
| Warfarin | Time to First Adjudicated ISTH MBE or CRNMBE | 264 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to First Adjudicated ISTH MBE or CRNMBE | 196 Participants |
Comparison: A pre-defined hierarchical testing approach was used. This was the first step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 110mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiority.p-value: <0.000195% CI: [0.42, 0.63]Regression, Cox
Comparison: A pre-defined hierarchical testing approach was used. This was the second step in hierarchy. The upper bound of the Wald confidence interval (CI) of the HR of Dabigatran Etexilate 150mg vs Warfarin (one-sided 97.5%) was compared with this noninferiority margin for the testing of non-inferiorityp-value: <0.000195% CI: [0.58, 0.88]Regression, Cox
Comparison: A pre-defined hierarchical testing approach was used. This was the fourth step in hierarchy.p-value: <0.00195% CI: [0.42, 0.63]Regression, Cox
Comparison: A pre-defined hierarchical testing approach was used. This was the sixth step in hierarchy.p-value: 0.00295% CI: [0.58, 0.88]Regression, Cox
Secondary
Time to Adjudicated All Cause Death
Time to event analysis of patients with adjudicated all cause death. The number of observed patients with adjudicated all cause death was reported. All cause death is defined as the death from any cause included CV death, non-CV death, and undetermined cause of death.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to Adjudicated All Cause Death | 55 Participants |
| Dabigatran Etexilate 150mg | Time to Adjudicated All Cause Death | 30 Participants |
| Warfarin | Time to Adjudicated All Cause Death | 48 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to Adjudicated All Cause Death | 35 Participants |
p-value: 0.557995% CI: [0.76, 1.65]Regression, Cox
p-value: 0.441495% CI: [0.51, 1.34]Regression, Cox
Secondary
Time to Adjudicated CV
Time to event analysis of patients with adjudicated Cardiovascular (CV) death. The number of observed patients with adjudicated Cardiovascular (CV) death was reported. CV death included death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to CV procedures, death due to CV haemorrhage, and death due to other CV causes.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to Adjudicated CV | 37 Participants |
| Dabigatran Etexilate 150mg | Time to Adjudicated CV | 21 Participants |
| Warfarin | Time to Adjudicated CV | 31 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to Adjudicated CV | 24 Participants |
p-value: 0.525295% CI: [0.72, 1.88]Regression, Cox
p-value: 0.56795% CI: [0.47, 1.51]Regression, Cox
Secondary
Time to Adjudicated Non-CV
Time to event analysis of patients with adjudicated Non-cardiovascular (Non-CV). The number of observed patients with adjudicated Non-CV was reported. Non-CV death was defined as any death with a specific cause that was not thought to be CV. These were possible examples of non-CV causes of death: Pulmonary, Renal, Gastrointestinal, Hepatobiliary, Pancreatic Infection(included sepsis), Inflammatory (e.g. systemic inflammatory response syndrome) or immune (including autoimmune), Haemorrhage that was neither CV bleeding nor a stroke, Non-CV procedure or surgery, Trauma, Suicide, Non-prescription drug reaction or overdose, Prescription drug reaction or overdose, Neurological (non-CV), Malignancy, Other non-CV
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to Adjudicated Non-CV | 14 Participants |
| Dabigatran Etexilate 150mg | Time to Adjudicated Non-CV | 4 Participants |
| Warfarin | Time to Adjudicated Non-CV | 13 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to Adjudicated Non-CV | 8 Participants |
p-value: 0.885395% CI: [0.5, 2.25]Regression, Cox
p-value: 0.23895% CI: [0.15, 1.61]Regression, Cox
Secondary
Time to Adjudicated Undetermined Cause of Death
Time to event analysis of patients with adjudicated Undetermined cause of death. The number of observed patients with adjudicated Undetermined cause of death was reported. This is referred to a death not attributable to cardiovascular (CV) death or to a non-cardiovascular (non-CV) cause. Inability to classify the cause of death may have been due to lack of information (e.g. the only available information was patient died) or when there was insufficient supporting information or detail to assign the cause of death.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to Adjudicated Undetermined Cause of Death | 4 Participants |
| Dabigatran Etexilate 150mg | Time to Adjudicated Undetermined Cause of Death | 5 Participants |
| Warfarin | Time to Adjudicated Undetermined Cause of Death | 4 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to Adjudicated Undetermined Cause of Death | 3 Participants |
p-value: 0.986295% CI: [0.25, 3.95]Regression, Cox
p-value: 0.527795% CI: [0.38, 6.64]Regression, Cox
Secondary
Time to Composite Endpoint of Death + MI + Stroke
Time to event analysis of patients with the composite endpoint of death + myocardial infarction (MI) + stroke. The number of observed patients with the composite endpoint of death + myocardial infarction (MI) + stroke was reported.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to Composite Endpoint of Death + MI + Stroke | 107 Participants |
| Dabigatran Etexilate 150mg | Time to Composite Endpoint of Death + MI + Stroke | 60 Participants |
| Warfarin | Time to Composite Endpoint of Death + MI + Stroke | 80 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to Composite Endpoint of Death + MI + Stroke | 57 Participants |
p-value: 0.048495% CI: [1, 1.79]Regression, Cox
p-value: 0.890395% CI: [0.71, 1.47]Regression, Cox
Secondary
Time to Composite Endpoint of Death or First Thrombotic Event
Time to event analysis of patients with composite endpoint of death or first thrombotic event (all death, myocardial infarction (MI), stroke/systemic embolism (SE)). The number of observed patients with composite endpoint of death or thrombotic event (all death, MI, stroke/SE).
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to Composite Endpoint of Death or First Thrombotic Event | 108 Participants |
| Dabigatran Etexilate 150mg | Time to Composite Endpoint of Death or First Thrombotic Event | 60 Participants |
| Warfarin | Time to Composite Endpoint of Death or First Thrombotic Event | 83 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to Composite Endpoint of Death or First Thrombotic Event | 60 Participants |
| All Dabigatran Etexilate | Time to Composite Endpoint of Death or First Thrombotic Event | 168 Participants |
Comparison: A pre-defined hierarchical testing approach was used. This was the fifth step in hierarchy.p-value: 0.112895% CI: [0.9, 1.53]Regression, Cox
p-value: 0.07295% CI: [0.98, 1.73]Regression, Cox
p-value: 0.87595% CI: [0.68, 1.39]Regression, Cox
Secondary
Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
Time to event analysis of patients with death or thrombotic event (all death, myocardial infarction, stroke/systemic embolism) or unplanned revascularisation by Percutaneous Coronary Intervention/Coronary Artery Bypass Graft. The number of observed patients with death or first thrombotic event or unplanned revascularisation by PCI/CABG was reported.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG | 149 Participants |
| Dabigatran Etexilate 150mg | Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG | 90 Participants |
| Warfarin | Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG | 131 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG | 98 Participants |
| All Dabigatran Etexilate | Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG | 239 Participants |
Comparison: A pre-defined hierarchical testing approach was used. This was the third step in hierarchy.p-value: 0.004795% CI: [0.84, 1.29]Regression, Cox
p-value: 0.300295% CI: [0.9, 1.43]Regression, Cox
p-value: 0.443295% CI: [0.67, 1.19]Regression, Cox
Secondary
Time to First Adjudicated MI
Time to event analysis of patients with first adjudicated Myocardial Infarction (MI). The number of observed patients with adjudicated MI was reported
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to First Adjudicated MI | 44 Participants |
| Dabigatran Etexilate 150mg | Time to First Adjudicated MI | 26 Participants |
| Warfarin | Time to First Adjudicated MI | 29 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to First Adjudicated MI | 22 Participants |
p-value: 0.086195% CI: [0.94, 2.41]Regression, Cox
p-value: 0.614495% CI: [0.66, 2.04]Regression, Cox
Secondary
Time to First Adjudicated SE
Time to event analysis of patients with first adjudicated Systemic embolism (SE). The number of observed patients with adjudicated SE was reported. SE is an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and had to be documented by angiography, surgery, scintigraphy, or autopsy.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to First Adjudicated SE | 3 Participants |
| Dabigatran Etexilate 150mg | Time to First Adjudicated SE | 1 Participants |
| Warfarin | Time to First Adjudicated SE | 3 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to First Adjudicated SE | 3 Participants |
p-value: 0.938895% CI: [0.19, 4.66]Regression, Cox
p-value: 0.30395% CI: [0.03, 2.93]Regression, Cox
Secondary
Time to First Adjudicated ST
Time to event analysis of patients with first adjudicated Stent Thrombosis (ST). The number of observed patients with adjudicated ST was reported.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to First Adjudicated ST | 15 Participants |
| Dabigatran Etexilate 150mg | Time to First Adjudicated ST | 7 Participants |
| Warfarin | Time to First Adjudicated ST | 8 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to First Adjudicated ST | 7 Participants |
p-value: 0.154695% CI: [0.79, 4.4]Regression, Cox
p-value: 0.978995% CI: [0.35, 2.81]Regression, Cox
Secondary
Time to First Adjudicated Stroke
Time to event analysis of patients with first adjudicated Stroke. The number of observed patients with adjudicated Stroke was reported. 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 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to First Adjudicated Stroke | 17 Participants |
| Dabigatran Etexilate 150mg | Time to First Adjudicated Stroke | 9 Participants |
| Warfarin | Time to First Adjudicated Stroke | 13 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to First Adjudicated Stroke | 8 Participants |
p-value: 0.480395% CI: [0.63, 2.67]Regression, Cox
p-value: 0.853795% CI: [0.42, 2.83]Regression, Cox
Secondary
Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
Time to event analysis of patients with adjudicated unplanned revascularisation by Percutaneous Coronary Intervention (PCI)/Coronary Artery Bypass Graft (CABG). The number of observed patients with adjudicated unplanned revascularisation by PCI/CABG was reported.
Time frame: up to 30 months
Population: Full Analysis set (FAS) following the intention-to-treat principle.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dabigatran Etexilate 110mg | Time to First Adjudicated Unplanned Revascularisation by PCI/CABG | 76 Participants |
| Dabigatran Etexilate 150mg | Time to First Adjudicated Unplanned Revascularisation by PCI/CABG | 51 Participants |
| Warfarin | Time to First Adjudicated Unplanned Revascularisation by PCI/CABG | 69 Participants |
| Warfarin (Excluding Elder Patients Outside USA) | Time to First Adjudicated Unplanned Revascularisation by PCI/CABG | 52 Participants |
p-value: 0.60895% CI: [0.79, 1.51]Regression, Cox
p-value: 0.834895% CI: [0.65, 1.41]Regression, Cox