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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,725
Active treatment
Active comparator
Active comparator
Active treatment
Active comparator
Active comparator
Active comparator
Active comparator
Active comparator
Cardiology P.C.
Birmingham, Alabama, United States
Verde Valley Medical Center
Cottonwood, Arizona, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
Arkansas Cardiology, PA
Little Rock, Arkansas, United States
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
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
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
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
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
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
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
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
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
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
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
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
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
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Mission Cardiovascular Research Institute
Fremont, California, United States
Aurora Denver Cardiology Associates, PC
Aurora, Colorado, United States
University of Florida College of Medicine
Jacksonville, Florida, United States
Watson Clinic, LLP
Lakeland, Florida, United States
Community Clinical Research Center
Anderson, Indiana, United States
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