Uninterrupted Dabigatran Etexilate in Comparison to Uninterrupted Warfarin in Pulmonary Vein Ablation (RE-CIRCUIT)
- Conditions
- Atrial Fibrillation
- Interventions
- Registration Number
- NCT02348723
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in Non-Valvular Atrial Fibrillation (NVAF) patients undergoing Atrial Fibrillation (AF) ablation in a PROBE (Prospective, randomized, open label, blinded end point) active controlled study.
Secondary objectives are to assess additional safety endpoints and efficacy in this clinical setting.
It is not intended to assess confirmatory hypothesis, this is an exploratory study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 678
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dabigatran Etexilate 150mg Dabigatran Etexilate 150mg Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID) Warfarin Warfarin Patients receiving Warfarin to keep International Normalized Ratio (INR) between 2.0 - 3.0
- Primary Outcome Measures
Name Time Method Incidence of Major Bleeding Events (MBEs), as Defined by the International Society on Thrombosis and Haemostasis (ISTH) during and up to 2 months post-ablation Major bleeds were defined according to the ISTH definition of a major bleed, as follows
* Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome and/or
* Bleeding associated with a reduction in haemoglobin of at least 2 g/dL (1.24 mmol/L), or leading to transfusion of 2 or more units of blood or packed cells. and/or
* Fatal bleed
These are based on adjudicated data (blinded evaluation)
Point estimates for the incidence of ISTH MBEs and their 2-sided 95% confidence intervals (CI), based on the normal approximation of independent binomial distribution without stratification, are presented.
- Secondary Outcome Measures
Name Time Method Incidence of the Composite of Stroke, Systemic Embolism, or Transient Ischemic Attack (TIA) during and up to 2 months post-ablation 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.
Systemic embolism was defined as an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts) and was to be documented by angiography, surgery, scintigraphy or autopsy.
Transient ischemic attack was defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.
These are based on adjudicated data (blinded evaluation).
Percentage of patients with composite of stroke, systemic embolism, or transient ischemic attack (TIA) is presentedIncidence of Minor Bleeding Events during and up to 2 months post-ablation Minor bleeds were clinical bleeds that did not fulfil the criteria for major bleeds. Percentage of patients with Minor bleeding events are presented.
These are based on adjudicated data (blinded evaluation)Incidence of ISTH MBE, Stroke, Systemic Embolism, or TIA (Composite Endpoint Combining Safety and Efficacy during and up to 2 months post-ablation Percentage of patients with ISTH MBE, stroke, systemic embolism, or TIA (composite endpoint combining safety and efficacy) are presented.
These are based on adjudicated data (blinded evaluation)
Trial Locations
- Locations (86)
Arkansas Cardiology, PA
🇺🇸Little Rock, Arkansas, United States
Mission Cardiovascular Research Institute
🇺🇸Fremont, California, United States
University of California
🇺🇸San Francisco, California, United States
Mercy Medical Group, a service of Dignity Health Medical Foundation
🇺🇸Sacramento, California, United States
Southwest Florida Research, LLC
🇺🇸Naples, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Elkhart General Healthcare System
🇺🇸Elkhart, Indiana, United States
Tulane University Hospital and Clinic
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
St. Louis Heart and Vascular, P.C.
🇺🇸Saint Louis, Missouri, United States
Scroll for more (76 remaining)Arkansas Cardiology, PA🇺🇸Little Rock, Arkansas, United States